Your single source for state-of-the-art needles and ... · [email protected] or...

Your single source for state-of-the-art needles and instruments. We proudly lead the market in providing the best in class echogenic needles for

ultrasound guided procedures.

Spectra Medical Devices, Inc. was founded in 1995 by Anthony C. Arrigo, (known as Tony Spectra) who was previously CEO, President and owner of American Medial Instruments, Inc. in Massachusetts, a market leader in manufacturing custom procedural needles, which is now the needle division of Tegra Medical.

Spectra Medical Devices has since become one of the largest procedural needle manufacturers in the world, with substantial market share in over 20 countries. Spectra utilizes the latest state-of-the-art manufacturing, measuring and inspection systems, along with over 200 years of senior staff needle manufacturing experience. Spectra has been awarded several US patents for special needle processing and product.

Our primary focus is on patient safety, achieving substantial growth through quality and innovation.Spectra has four manufacturing plants worldwide employing over 200 personnel. Our corporate headquarters is located in Wilmington, Massachusetts.

1Spectra Medical Devices, Inc. 978.657.0889 | spectramedical.com

WELCOME


INDEX

ISO Certificates 3-4

Epidural Needles 5-9

Catheter Introducer Needles 10

Guidewire Introducer Needles 11

FNA Biopsy Needles 12

Echogenic Needles 13-16

Spinal Needles 17-18

Radio Frequency Needles 19-20

Huber Needles and Cannula 21-23

Packaged Sterilized Needles 24

Scalpels 25-26

Tunnelers and Trocar 27

Kit Components 28

Loss of Resistance Syringes 29

Ampoule Opener 30

Disposable Instruments 31

Tubes and Fabrication 32

Tubing and Wiring Gauge Chart 33-34

Glossary of Terms 35-37

Color Chart 38


In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. This certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to whom it must be returned upon request. CT-ISO 9001-2008-ANAB-EN-LT-L-26.jun.15

Spectra Medical Devices, Inc.

Main Site: 260-H Fordham Road, Wilmington, Massachusetts, 01887, USA Additional site: 2008, Anam Tower, 311, Teheran-ro, Gangnam-gu, Seoul, Korea 06151

Main Site: The design, manufacture and sales of disposable medical needles and other disposable medical devices, as well as the management of contract manufacturing and private labeling services. Additional Site: Sales / Purchasing.

Certificate of Registration

This is to certify that the quality management system of

has been assessed and registered by Intertek as conforming to the requirements of ISO 9001:2008

The quality management system is applicable to

Certificate Number: Initial Certification Date: Certificate Issue Date: Certificate Expiry Date:

QMS-0563-4-01 12 May 2010 12 May 2016 14 September 2018

Calin Moldovean, President Intertek Testing Services NA, Inc.

900 Chelmsford Street, Suite 301-3, Lowell, MA, USA

CERTIFICATIONS


In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification Agreement. This certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to whom it must be returned upon request. CT-ISO13485:2003-SCC-EN-LT-L-15.may.15

Spectra Medical Devices, Inc.

Main Site: 260-H Fordham Road, Wilmington, Massachusetts, 01887, USA Additional site: 2008, Anam Tower, 311, Teheran-ro, Gangnam-gu, Seoul, Korea 06151

Main Site: The design and manufacture of disposable medical needles and other disposable medical devices, as well as the management of contract manufacturing and private labeling services.

Additional Site: Sales / Purchasing.

Certificate of Registration

This is to certify that the quality management system of

has been assessed and registered by Intertek as conforming to the requirements of

ISO 13485:2003 The quality management system is applicable to

Certificate Number: Initial Certification Date: Certificate Effective Date: Certificate Expiry Date:

SCC-0076-4-01 12 May 2010 12 May 2016 28 February 2019

Calin Moldovean, President

Intertek Testing Services NA Ltd., 1829, 32nd avenue, Lachine, QC, H8T 3J1, Canada

CERTIFICATIONS


PlasTIC HUB

FEATURES:

• 510(k) cleared

• CE marked

• Cath Slide® process ensures unscathed catheter advancement and retraction

• Epi-Match® ground needles

• ISO 80369-6 compliant hubs available

• Uses highest tensile 304 stainless steel available

• Metal or plastic stylet

• Metal or plastic hub

• Without wing, fixed wing or removable wing

• Customized sharpness regular | dull | super dull

• Available with cm depth markings

• Transparent hub for full visualization of fluids

• Bevel orientation indicator assures proper alignment

• Color-coded stylet cap (refer to page 38)

• Transparent needle protector

• Disposable, single use

EPIDURAL NEEDLES

13 GA - 25GA | 2" - 8" lengthscustom sizes available upon request

Pajunk style

Unisis style

Sizes:

Removable wing


Metal Hub

FEATURES:

• 510(k) cleared

• CE marked

• Cath Slide® process ensures unscathed catheter• advancement and retraction

• Epi-Match® ground needles



• Available with cm depth markings

• Weiss style available

• Disposable, single use

APPLICATIONS:

• Regional anesthesia• Hydrocephalus shunting

EPIDURAL NEEDLES


Sizes:

Tuohy Style Hustead Style Crawford Style


EPIDURAL NEEDLES

FEATURES:

• 510(k) cleared

• CE marked



• Prevents coring and plugging

• Smoother, easier advancement of needle and catheter

• Plastic or metal hubs

• Customized sharpness regular | dull | super dull

• Available in Tuohy | Hustead | Crawford styles

APPLICATIONS:• Pain Management• Regional anesthesia• Hydrocephalus shunting

Epi-Match®

Spectra epidural needles are available in the EPI-MATCH design, featuring match-bent and match-ground bevels, as designed by Dr. Tuohy and Hustead. Match-grinding the stylet and bevel as one set eliminates dangerous protrusions at the tip or recessions at the heel found with non-match-ground needles. This reduces possibility of resistance during catheter insertion and advancement, and enhances patient safety.

All bevels preciselymatch-ground from

tip to heel


Sizes:


EPIDURAL NEEDLES

Epi-Match®

Unaltered photographs of our competitors’ packaged and sterile products.You can clearly see the quality difference between EPI-MATCH Spectra needles compared to 5 examples of lower quality and lower cost non-match-ground competitor's epidural needles.

Brand TCBrand UN Brand BB

EPI-MATCH Spectra needle


EPIDURAL NEEDLES

Cath Slide®

Cath Slide epidural needles receive a patented Spectra blasting process that

rounds all internal edges for easier and safer catheter manipulation.

What can happen if the heel area is not treated with Cath Slide®

Actual field photographs of damaged catheters

All internal edges are completely rounded

FEATURES:

• 510(k) cleared

• CE marked



• Eliminates cutting, skiving and hanging up of the catheter

• Smoother advancing and retracting


• Available in Tuohy | Hustead | Crawford styles

APPLICATIONS:

• Pain management

• Epidural catheter placement

Shearing Fracturing Slicing


Sizes:


FEATURES:



• Eliminates catheter cutting, skiving and hang ups

• Smoother advancement and retraction


• With or without calibration markings

• Curved or straight

• Plastic stylet available

APPLICATIONS:

• Intrathecal Drug Delivery

• Neurostimulation

CATH GLIDE® SPINAL CORD STIMULATION CATHETER INTRODUCER

Internal and external edges are completely rounded in order to facilitate the advancing and retracting of catheters and catheters with external electrodes without skiving, breaking or stopping.

For safe and sure catheter and electrode introduction


Sizes:

CATHETER Introducer NEEDLES


GUiDEWIRE INTRODUCER NEEDLES

FEATURES:

• 510(k) cleared

• CE marked


• Lubricated or non-lubricated

• Dimpled echogenic, blasted echogenic or non-echogenic

• Widest array of plastic hub styles available

• Available in A or B bevel

• Optional bevel indicator

• Seldinger, Potts Courner, Modified Potts

• Blunt needles available

• Sterile or non-sterile

APPLICATIONS:• Angiography• Angioplasty• PICC trays

GuideWIRE INTRODUCER NEEDLES Guide Glide II® is our echogenic configuration, which optimizes needle image under ultrasound guidance for accurate placement and reducing unnecessary patient trauma.

17 GA - 22GA | 1.25" - 7" lengthscustom sizes available upon request

Sizes:

Guide Glide II® under ultrasound


GUiDEWIRE INTRODUCER NEEDLES FNA - FINE NEEDLE Aspiration Biopsy Needles

Franseen, Greene, Westcott and Chiba

FEATURES:

• 510(k) cleared

• CE mark pending



• Dimpled echogenic, echogenic blasted or non-echogenic tip

• Plastic or metal hub

• Calibration markings or no calibration markings

• Color-coded stylet hub for instant gauge identification

• Depth stop available

18 GA - 27 GA | 7cm - 20cm lengthscustom sizes available upon request

Sizes:

Franseen Greene Whitacre Chiba


FEATURES:

• 510(k) pending



• Inner diameter unaffected by echogenic field so catheter slides smoothly

• Available in Tuohy | Hustead | Crawford | Weiss styles

APPLICATIONS:

• Peripheral nerve blocks

• Pain management

SPECTRA GUIDE™ Echogenic NeedlesEchogenic needles allow you to see and precisely guide, advance and locate in order to perform

procedures more efficiently. Spectra’s dimpled echogenic field provides maximum recapture rate

for the clearest image under ultrasound guidance.

For ultrasound-guidedinjections and

catheter placement


Sizes:

ECHOGENIC - PERIPHERAL NERVE BLOCK (PNB)


ECHOGENIC - PERIPHERAL NERVE BLOCK (PNB) ECHOGENIC - TUOHY NERVE BLOCK

Spectra Tuohy Ultrasonic outperforms Pajunk TuohySono

Spectra Tip

Pajunk Tip

Spectra Needle

Pajunk Needle

Background and Objective:The objective of this study was to evaluate the use of Spectra Medical’s Tuohy-Ultrasonic Needle 17G versus Pajunk TuohySono cannula 17G in real conditions. The main purpose was to validate which needle possessed superior, affective, and accurate echogenicity.

Methods

Results

The two needles were inserted in the same piece of beef of 10 x 8 cm. The images were made with Sonosite EDGE with HFL50x 15-6MHz transducer.

Images were made first, out of plane side by side, to compare the echogenicity of the tip of these needles.

Then, images were made in plane in the same area and the same depth. The purpose is to see the bevel of this needles and to see the sharpness under ultrasound procedure

In my professional opinion the best and safest needle is the Spectra Medical Tuohy-Ultrasonic 17G. During a procedure, your target is to place the needle near by a structure, which is below your needle. If you challenge it in a important acoustic shadow, you loose in precision and in safety for your patient.

Pajunk 17G vs Spectra 17GOut of plane image

Pajunk TuohySono 17GIn plane image

Out of plane image: The tip of Spectra Medical’s Tuohy-UltraSononic Needle 17G appears more clearly, as a flashy point, very sharp without any acoustic shadow under it. The tip of the Pajunk TuohySono 17G out of plane appears with large artifacts around it. There is anoticeable halo above the tip and an acoustic shadow under, which is very significant on 1 cm.

In plane images:In these images we can see that the Spectra Medical’s Tuohy-UltraSononic needle has got a good echogenicity without any acoustic shadow. The bevel is very bright and the sharpness of the image can give confidence for his right placement. The Pajunk TuohySono 17G image is bright but is not very precise with a significant acoustic shadow because of the coating of this needle.

Spectra Medical Tuohy-Ultrasonic Needle 17G vs Pajunk TuohySono cannula 17G

Author : G. Destruhaut Head of Anesthesiology at Saint LOUIS Clinic, Le Bouscat, France.This test was conduced on my own behalf and unsolicited from Spectra Medical

Conclusion


ECHOGENIC - MSK NEEDLES

Spectra Ultrasonic outperforms Pajunk and B Braun Stimuplex Duo

Brand TCMSK NEEDLES Peripheral Joint Injection

FEATURES:

• 510(k) cleared

• CE mark pending



• B Bevel

Background and aims:The aim of this study was to evaluate the use of Spectra Medical Ultrasonic Needle 21G versus Pajunk Sonoplex 22G and B Braun Stimuplex Duo 22G in real condition. The main purpose was to validate the echogenicity of these needles, to compare them and to determine the safer choice.

CONCLUSION

Author : G. Destruhaut Head Anesthesiology of Saint LOUIS Clinic, Le Bouscat, France.This test was conduced on my own behalf and unsolicited from Spectra Medical

Results

The three needles were inserted in the same piece of beef of 10x 8 cm. The images were made with Sonosite EDGE with HFL50x 15-6MHz transducer.

Images were first made out-of-plane, side-by-side, to compare the echogenicity of the tips of the needles.

Then, images were made in plane in the same area and the same depth. The purpose to see the bevel of this needles and to see the sharpness of the image under ultrasound procedure.

According to my results, the best and safest needle is the Spectra Medical’s UltraSononic Needle 21G. Its echo-genicity is excellent and its image very sharp, allowing precise placement of this needle.

Spectra Medical UltraSononic 21G

In plane image

Pajunk Sonoplex

In plane image

Out of plane image: The tip of Spectra Medical’s UltraSononic needle 21G appears more clearly, as a sharp, flashy point without any acoustic shadow under it. The tip of the B Braun Stimuplex Duo needle appears with an image obstructing halo above the tip and an acoustic shadow underneath which, distorts the image. The tip of Pajunk Sonoplex Needle appears with a smaller echo and a lower echogenicity.

In plane images:In these images we can see that the Spectra Medical’s UltraSononic needle has a good echogenicity without any acoustic shadow. The bevel is very bright and the sharpness of the image can give confidence for accurate place-ment. The Pajunk Sonoplex image is bright but it is difficult to determine the exact location of the tip. The B Braun Stimuplex Duo appears on a much lower echogenic recapture level than either needle.

B Braun Stimuplex Duo

In plane image

Spectra Medical Ultrasonic Needle 21G vs Pajunk Sonoplex and B Braun Stimuplex Duo

B Braun Stimuplex Duovs Pajunk Sonoplex vs Spectra Medical’sOut of plane image


Ultrasound guided musculoskeletal (MSK) injections require clear needle tip visualization for safe and accurate needle placement. This is the first needle designed specifically for MSK injections that addresses the necessity of a superiorly enhanced echogenic needle tip so that it can be easily distinguished in the presence of tendons and ligaments. In addition, a firm metal alloy with a small gauge permit improves tissue navigation and patient comfort. The net effect is a quicker and more efficacious procedure.

Dr. Thomas Simopoulos, MDAnesthesiology and Pain Medicine at Beth Israel Deaconess Medical Center

Sizes:

ECHOGENIC - Prostate Seed IMplant NEEDLES

Prostate Seed Implant NeedleSpectra’s echogenic design creates superior recapture and the clearest circumferential brightvisualization of the needle tip under ultrasound guided procedures.

FEATURES:

• 510(k) cleared


• Metal or plastic hub

APPLICATIONS:

• Prostate Seed Implantation

18 GA | 8" lengthcustom sizes available upon request

Sizes:


SPINAL NEEDLES

Quincke, Chiba, SPROTTE and PENCIL PointSQuincke, Chiba, Sprotte and Pencil Points, featuring Spectra’s EPI-MATCH® match ground bevels to preventcoring and plugging, available in a choice of sizes and configurations to match any procedure and preference.

FEATURES:

• 510(k) cleared

• CE mark pending



• Available with or without introducer needles

• Available with or without cm markings

• Clear, plastic hubs with color-coded stylet caps

• Optional bevel orientation indicators

• Depth stop available


Quincke Chiba Sprotte Whitacre

Sizes: 18 GA to 27 GA

Lengths: 4 cm(1.5”) to 30.5 cm(12”)

custom sizes available upon request

Depth Stop

Franseen

SPINAL NEEDLES

Block Glide® LUBRICATED SPINAL NEEDLEQuincke, Chiba, Sprotte and Pencil Points are available in Block Glide configurations, featuring our patented lubri-cation, making any procedure easier for providers and patients alike.

Spinal Introducer NeedlesFEATURES:



• Aluminium, metal or plastic hubs

• Knurled Hub

• Smooth transition for needle insertion and passage


Sharper points and lubrication make a real difference in patient comfort

19 GA - 22 GA | 1" - 3.5" lengthscustom sizes available upon request

Sizes:

RADIO FREQUENCY NEEDLES (RF)


RAF Reduced Advanced Force® Radio Frequency NEEDLES, SAC-TRA®

For various RF probes, electrodes and devices used in procedures including ablations to create a heat lesion ontarget nerves. Spectra offers a wide range of optimized needle designs that minimize patient discomfort and maximize control and results.

Sac-Tra® Radio Frequency INTRODUCERGuided Injections for RF needlesSpectra Medical Devices patent pending Sac-Tra® needle allows for the introduction of a smaller gauge Radio Frequency needle into deeper, firm structures next to the vertebral bodies, intervertebral discs, and sacroiliac joint. The introducer needle is curved to allow easy navigation as well as enhance the direction of the introduced needle.

FEATURES:

• 510(k) cleared

• CE mark pending


• Customizable gauges, lengths and active tip lengths

• With or without hub

• Straight, curved, blunt or sharp tips

• Echogenic or non-echogenic

• Lubricated or non-lubricated

• Available in quincke bevel or lancet bevel

FEATURES:

• Elongated bevel for easy advancement of RF needle and electrode

• Sturdy 14ga design allows finer needles for easier manipulation through the body

• Available straight or curved

APPLICATIONS:• Nerve heat lesion

RADIO FREQUENCY NEEDLES (RF)


What makes Spectra Reduced Advance Force® Needles Superior?Spectra Reduced Advance Force® needles have been double heat sealed to eliminate the chance of coating retraction and to dramatically reduce the transition point from RF coating to active tip.

Brand X Brand X Spectra (RAF®)

Traumatic transition increases pain/discomfort to patient.Loose particulates could become dislodged in the patient

Inadequate heat sealing allows the RF coating to retract during insertion causing a larger active tip area than intended

Smooth double sealed transition

HUBER NEEDLES AND CANNULA

21Product Catalog Title 978.657.0889 | spectramedical.com

HUBER NEEDLES AND CANNULASSpectra Huber Needles and Cannulas have literally set the design and quality benchmark for the world.They are available in standard and custom configurations to meet the needs and preferences of caregivers and vendors around the port.

Plastic HubFEATURES:• 510(k) cleared• Uses highest tensile 304 stainless steel available • Straight or bent • Color-coded plastic hubs

Metal Hubs

FEATURES:• 510(k) cleared• Uses highest tensile 304 stainless steel available • Straight or bent

Cannula Only

FEATURES:• Custom made to customer specifications

• Straight or bent

HUBER NEEDLES


Port Glide ™As the technology leader in non-coring needles, Spectra’s Port Glide combines our wide arrayof Huber Needles with proprietary lubrication which greatly reduces insertion and retraction force when entering and exiting the port. This results in minimal patient discomfort.

The most important breakthrough in the Non-coring Huber Needle Assemblies Market for safety and patient comfort since the advent of sub-dermal ports in 1984.

FEATURES:

• Lubrication reduces patient discomfort

• Lubrication reduces insertion and retraction force necessary

• Plastic or metal hub

• Straight or curved

APPLICATIONS:

• Portal Access Therapy

• Implantable Drug Delivery Systems

HUBER NEEDLES


Do Your Huber Needles Comply with FDA Standards?With the recall of over 2,000,000 Huber needles, the issue became what constitutes a true Non-Coring Huber needle and what can be done to insure patient safety and protect your business. As the global industry leader, Spectra was asked to work with the FDA to set the parameters and standards for true non-coring Huber needles.

Packaged STERILIZED NeeDLes


Spectra offers packaged sterilized needles and other medical devices in a series of Tyvek™ chevronpeel pouches with a standard single color 2” x 4” label in a white chipboard or fluted shelf box. A strong experienced Quality Control Department, and validated packaging and sterilization processes, support this offer. The packaging facility with a class 100,000 cleanroom, and the state-of-the-art sterilization facility, have ISO 13485 certification.

Spectra will provide appropriate studies establishing SAL, Bioburden, Non-Pyrogenicity, Nontoxicity,package integrity and EtO residuals, as well as bacteriostasis and fungistasis for the standard products.Spectra will also work with customers for custom needle requirements to address testing and validation needs for their specific product requirements.

Spectra’s new dedicated packaging facility with fully validated packaging processes is available for our current contract packaged sterile needles, and for customers looking for contracted packaging solutions to market their products as quickly and easily as possible; with an array of packaging options to meet the customer's needs; private labeled of products, and EtO sterilization.

Very competitive pricing and short lead times

ScalpELS

FEATURES:

• Class I device

• CE Marked

• Top activation button enables left- and right handed use

• Audible button click and tactile sensation confirms lock is in place

• Tactile ruler on side

Safe-Cut ® and safe-cut ® mini Safety ScalpelSpectra is the only company to offer a Safety Scalpel that is 510(k) cleared and meets the FDA injury and prevention guidance.


#10 | #11 | #15 Sizes:

Precise holes for PICCcatheter straight cutting


Scalpels/BladesBoth scalpels and standalone blades available

SCALPELS

#10 | #11 | #12 | #15 | #20 | #21 | #22 #23 | #24 | #25 | #10A | #12B | #15C

Sizes:

TUNNELER AND TROCAR


FEATURES:

• Class I devices

• Available in various styles and lengths

Tunneler and wound drainage trocar

KIT COMPONENTS

Strap Clips


Sponges• Coarse Sponge Sticks (50 pores/sq in)

• Fine Sponge Sticks (70 pores/sq in)

• Straight

• Angled

• Oral swab

Loss of Resistance Syringes

Spectra-Glass LOR Syringes

FEATURES:

• 510(k) cleared

• ISO 80369-6 compliant luer available

• Smooth, consistent, low friction plunger movement

• Available sterile and bulk non-sterile

Sizes:

Metal Luer Slip: 3cc ,5cc ,10cc

Metal Luer Lock: 3cc ,5cc ,10cc

Glass Luer Slip: 3cc ,5cc ,10cc


Ampoule Opener


Red Snapper ®Prevents sharp related injuries

FEATURES:

• Biohazard Color-Coded

• Makes for easy disposal of ampoule neck

• Reduces the risk of injuries

1 - 4 ml Ampoules

5-10 ml Ampoules

11 -20 ml Ampoules

Sizes:

Easy as 1, 2, Snap

DISPOSABLE INSTRUMENTS


Surgical and Dental InstrumentsAll Instruments are FDA Compliant. Our catalog has over 250 illustrated pages of specialized surgical and dental instruments completing the full spectrum of custom trays.Catalog available upon request.

FEATURES:

• Industry standard floor grade available

• Premium grade instruments available

• 100% USA inspected parts available

Diagnostic

Anesthesia

Trocars

General Instruments

Suture

Plaster

Bone Surgery

Lung Surgery

Cardiovascular

Neuro Surgery

Ophthalmology

Otology

Rhinology

Oral Instruments

Tonsil

Esophagoscopy

Tracheotomy

Goiter

Intestines I Stomach

Rectum

Gall Bladder

Urology

Obstetrics

Sterilization

Orthopedic

Dermatology

Tubes and Fabrication

STAINLESS Steel Tubing WIRE


FEATURES:

• Radiusing available upon request

• Available to .2-10ft length

• 304, 304L, 316, 316L

TUBING AND WIRING Gauge Chart


6 RW .2020-.2040 .1700-.1760 0.0150 TW .2020-.2040 .1800-.1860 0.0100 7 RW .1790-.1810 .1470-.1530 0.0150 TW .1790-.1810 .1570-.1630 0.0100 8 RW .1640-.1660 .1320-.1380 0.0155 TW .1640-.1660 .1420-.1480 0.0100 9 RW .1470-.1490 .1150-.1210 0.0150 TW .1470-.1490 .1250-.1310 0.0100 RW .1330-.1350 .1040-.1080 0.0140 TW .1330-.1350 .1120-.1160 0.0100 10 ETW .1330-.1350 .1160-.1200 0.0080 UTW .1330-.1350 .1200-.1240 0.0060 MTW .1330-.1350 .1240-.1280 0.0040 RW .1190-.1210 .0920-.0960 0.0130 TW .1190-.1210 .0980-.1020 0.0100 11 ETW .1190-.1210 .1020-.1060 0.0080 UTW .1190-.1210 .1060-.1100 0.0060 MTW .1190-.1210 .1100-.1140 0.0040 RW .1080-.1100 .0830-.0870 0.0120 TW .1080-.1100 .0890-.0930 0.0090 12 ETW .1080-.1100 .0930-.0970 0.0070 UTW .1080-.1100 .0970-.1010 0.0050 MTW .1080-.1100 .1010-.1050 0.0030 RW .0940-.0960 .0690-.0730 0.0120 TW .0940-.0960 .0750-.0790 0.0090 13 ETW .0940-.0960 .0790-.0830 0.0070 UTW .0940-.0960 .0830-.0870 0.0050 MTW .0940-.0960 .0880-.0920 0.0030 RW .0820-.0840 .0610-.0650 0.0100 TW .0820-.0840 .0660-.0685 0.0080 14 ETW .0820-.0840 .0710-.0730 0.0055 UTW .0820-.0840 .0730-.0760 0.0045 MTW .0820-.0840 .0760-.0790 0.0030

RW .0715-.0725 .0525-.0555 0.0090 TW .0715-.0725 .0595-.0615 0.0060 15 ETW .0715-.0725 .0615-.0635 0.0050 UTW .0715-.0725 .0635-.0655 0.0040 MTW .0715-.0725 .0655-.0675 0.0030 RW .0645-.0655 .0455-.0485 0.0080

TW .0645-.0655 .0525-.0545 0.0060 16 ETW .0645-.0655 .0545-.0565 0.0050 UTW .0645-.0655 .0565-.0585 0.0040 MTW .0645-.0655 .0585-.0605 0.0030 RW .0575-.0585 .0405-.0435 0.0080 TW .0575-.0585 .0465-.0485 0.0050 17 ETW .0575-.0585 .0490-.0510 0.0040 UTW .0575-.0585 .0510-.0530 0.0030 MTW .0575-.0585 .0530-.0550 0.0020 RW .0495-.0505 .0405-.0435 0.0085 TW .0495-.0505 .0375-.0395 0.0060 18 ETW .0495-.0505 .0410-.0430 0.0040 UTW .0495-.0505 .0430-.0450 0.0030 MTW .0495-.0505 .0450-.0470 0.0020

RW .0415-.0425 .0255-.0285 0.0075 TW .0415-.0425 .0315-.0335 0.0050 19 ETW .0415-.0425 .0340-.0360 0.0035 UTW .0415-.0425 .0360-.0380 0.0025 MTW .0415-.0425 .0380-.0400 0.0015

RW .0355-.0360 .0230-.0245 0.0060

TW .0355-.0360 .0255-.0270 0.0050

20 ETW .0355-.0360 .0270-.0285 0.0040 UTW .0355-.0360 .0290-.0305 0.0030 MTW .0355-.0360 .0310-.0325 0.0020 RW .0320-.0325 .0195-.0210 0.0060 TW .0320-.0325 .0225-.0240 0.0045 21 ETW .0320-.0325 .0245-.0260 0.0035 UTW .0320-.0325 .0265-.0280 0.0025 MTW .0320-.0325 .0285-.0300 0.0015

Gauge Wall Type OD Range ID Range Wall Gauge Wall Type OD Range ID Range Wall

RW .0715-.0725 .0525-.0555 0.0090 TW .0715-.0725 .0595-.0615 0.0060 15 ETW .0715-.0725 .0615-.0635 0.0050 UTW .0715-.0725 .0635-.0655 0.0040 MTW .0715-.0725 .0655-.0675 0.0030 RW .0645-.0655 .0455-.0485 0.0080

TW .0645-.0655 .0525-.0545 0.0060 16 ETW .0645-.0655 .0545-.0565 0.0050 UTW .0645-.0655 .0565-.0585 0.0040 MTW .0645-.0655 .0585-.0605 0.0030 RW .0575-.0585 .0405-.0435 0.0080 TW .0575-.0585 .0465-.0485 0.0050 17 ETW .0575-.0585 .0490-.0510 0.0040 UTW .0575-.0585 .0510-.0530 0.0030 MTW .0575-.0585 .0530-.0550 0.0020 RW .0495-.0505 .0405-.0435 0.0085 TW .0495-.0505 .0375-.0395 0.0060 18 ETW .0495-.0505 .0410-.0430 0.0040 UTW .0495-.0505 .0430-.0450 0.0030 MTW .0495-.0505 .0450-.0470 0.0020

RW .0415-.0425 .0255-.0285 0.0075 TW .0415-.0425 .0315-.0335 0.0050 19 ETW .0415-.0425 .0340-.0360 0.0035 UTW .0415-.0425 .0360-.0380 0.0025 MTW .0415-.0425 .0380-.0400 0.0015

RW .0355-.0360 .0230-.0245 0.0060

TW .0355-.0360 .0255-.0270 0.0050

20 ETW .0355-.0360 .0270-.0285 0.0040 UTW .0355-.0360 .0290-.0305 0.0030 MTW .0355-.0360 .0310-.0325 0.0020 RW .0320-.0325 .0195-.0210 0.0060 TW .0320-.0325 .0225-.0240 0.0045 21 ETW .0320-.0325 .0245-.0260 0.0035 UTW .0320-.0325 .0265-.0280 0.0025 MTW .0320-.0325 .0285-.0300 0.0015

TUBING AND WIRING Gauge Chart


RW .0280-.0285 .0155-.0170 0.0060 TW .0280-.0285 .0190-.0205 0.0040 22 ETW .0280-.0285 .0215-.0230 0.0030 UTW .0280-.0285 .0235-.0250 0.0020 MTW .0280-.0285 .0255-.0270 0.0010 RW .0250-.0255 .0125-.0140 0.0060 TW .0250-.0255 .0165-.0180 0.0040 23 ETW .0250-.0255 .0185-.0200 0.0030 UTW .0250-.0255 .0205-.0220 0.0020 MTW .0250-.0255 .0225-.0240 0.0010 RW .0220-.0225 .0115-.0130 0.0050 TW .0220-.0225 .0135-.0155 0.0040 24 ETW .0220-.0225 .0155-.0170 0.0030 UTW .0220-.0225 .0175-.0190 0.0020 MTW .0220-.0225 .0195-.0210 0.0010 RW .0200-.0205 .0095-.0110 0.0050 TW .0200-.0205 .0115-.0130 0.0040 25 ETW .0200-.0205 .0135-.0150 0.0030 UTW .0200-.0205 .0155-.0170 0.0020 MTW .0200-.0205 .0175-.0185 0.0010 RW .0180-.0185 .0095-.0110 0.0040 TW .0180-.0185 .0115-.0130 0.0030 26 ETW .0180-.0185 .0130-.0145 0.0020 UTW .0180-.0185 .0145-.0155 0.0015 MTW .0180-.0185 .0155-.0165 0.0010 RW .0160-.0165 .0075-.0090 0.0040 TW .0160-.0166 .0095-.0110 0.0030 27 ETW .0160-.0165 .0115-.0130 0.0020 UTW .0160-.0165 .0130-.0140 0.0015 MTW .0160-.0165 .0140-.0150 0.0010 RW .0140-.0145 .0065-.0080 0.0035 TW .0140-.0 145 .0085-.0100 0.0025 28 ETW .0140-.0145 .0100-.0110 0.0020 UTW .0140-.0145 .0110-.0120 0.0015 MTW .0140-.0145 .0120-.0130 0.0010

RW .0130-.0135 .0065-.0080 0.0030 TW .0130-.0135 .0080-.0090 0.0025 29 ETW .0130-.0135 .0090-.0100 0.0020 UTW .0130-.0135 .0100-.0110 0.0015 MTW .0130-.0135 .0110-.0120 0.0010

RW .0120-.0125 .0055-.0070 0.0030

TW .0120-.0125 .0070-.0080 0.0025

30 ETW .0120-.0125 .0080-.0090 0.0020

UTW .0120-.0125 .0090-.0100 0.0015 MTW .0120-.0125 .0100-.0110 0.0010

RW .0100-.0105 .0040-.0055 0.0025

TW .0100-.0105 .0055-.0070 0.0020 31 ETW .0100-.0105 .0070-.0080 0.0015 UTW .0100-.0105 .0080-.0090 0.0010

RW .0090-.0095 .0035-.0050 0.0025

32 TW .0090-.0095 .0050-.0060 0.0020 ETW .0090-.0095 .0060-.0070 0.0015 UTW .0090-.0095 .0070-.0080 0.0010 RW .0080-.0085 .0035-.0050 0.0020 33 TW .0080-.0085 .0050-.0060 0.0015 ETW .0080-.0085 .0060-.0070 0.0010

RW .0070-.0075 .0025-.0040 0.0020 34 TW .0070-.0075 .0040-.0050 0.0015 ETW .0070-.0075 .0060-.0070 0.0015

35 RW .0050-.0055 .0015-.0030 0.0015 TW .0050-.0055 .0030-.0040 0.0010 36 RW .0040-.0045 .0050-.0060 0.0015 TW .0040-.0045 .0060-.0070 0.0010

Gauge Wall Type OD Range ID Range Wall Gauge Wall Type OD Range ID Range Wall

GLOSSARY OF TERMS


AQL (ACCEPTABLE QUALITY LEVELS): A statistical method of sampling by which a predetermined percentage of parts can be accepted as a process average.

ANGLE OF ROTATION: The included angle of the Diamond Point.

ANNEAL: To subject metal to high heat with a subsequent cooling to make it more malleable.

ANODIZE: To subject aluminum to an electrolytic action in order to coat it with a protective film.

ANTICORE BLAST: A blasting operation to dull the heel of the bevel in order to reduce coring.

ASSEMBLY: A cannula plus a hub (also may include packaging and/or protective material or internal components such as filters, diaphragms, etc.

BEVEL: The angled surface formed on the cannula when a needle point is ground. A typical diamond point has three bevels. The main bevel is partially ground away to form two side bevels.

BEVEL LENGTH: The longest distance of the bevel, usually measured from the tip of the needle to the most proximal area of grinding behind he heel. Side Bevel Length is measured between 1) the juncture of side bevel and the outside surface of tubing and 2) the tip of the needle.

BURRS: Deflection of the point, perceptible to feel.

CANNULA: Small pointed hollow stainless steel tube for insertion into the body (When hub is added it becomes a “NEEDLE”).

CHAMFER: The blending of the O.D. into the I.D., which is formed by angle or radius.

CLEAN: Free from dirt of pollution (Not sterile).

CORING: The cutting of a plug of tissue or port septum when the needle passes through.

CRUXE: The point of the inside wall where the primary and secondary angle meet after rotation.

CUTOFF: Tubing cut to length with no round bevel.

DIAMOND POINT: The length of the secondary angle after rotation, which is measured from the tip to the longest outside grind.

DISTAL END: The end of the needle farthest from the hub.

FEATHER: A thin portion of metal on the cannula that could potentially break off during use.

FLARE: To spread or curve outward. Pertaining to a cannula, it is the spreading of the tubing to a larger diameter.

FLASH: Excessive material on plastic, usually occurring at the mold parting lines.

FREE LENGTH (or NEEDLE LENGTH): The distance between the point of the cannula and the point where the hub starts; i.e., the distance the cannula is exposed only---not covered by the hub. Sometimes referred to as USABLE LENGTH.

GG-N-00193: Interim Federal Specification covering sterile disposable hypodermic needles with regular bevel point.

GLOSSARY OF TERMS


GG-N-196: U.S. Government Specification regarding medical cannula and needles.

GAUGE: O.D. of the needle or cannula, expressed as a Stubs Gauge Number (See tubing specification chart).

GRIT BLAST: An extra heavy blast on the heel for 1) anti-coring, or 2) to roughen the O.D. of the cannula.

HEEL OF BEVEL: The proximal rounded inner-edge of the point lumen.

HOOK: A burr where a deflection of the point is in excess of .002 inches.

HUB: Part attached to the cannula to make a needle, to enable it to be attached to a syringe of other device.

HUBER POINT: A point which is bent to allow the opening to be on he side.

I.D.: Internal diameter of tubing.

INTRA-ARTERIAL: Within an artery.

INTRADERMAL: Within the skin.

INTRAMUSCULAR: Within the substance of a muscle.

INTRAVENOUS: Within a vein.

INSERT MOLDING: Method of inserting a cannula during a plastic molding process.

LUER LOCK: A part which locks a needle to a syringe by means of a threated hub.

LUER TAPER: This taper is standardized by the American Standard Association’s Standard 270.1-1955.

LUMEN: The hole through the cannula tube.

MICRON: A unit of length -- a thousandth part of one millimeter.

NEEDLE (or NEEDLE ASSEMBLY): A cannula with a hub attached.

O.D.: Outside diameter of tubing.

OBTURATOR: A solid rod having a handle, used to occlude the lumen of a needle.

OCCLUDE: To block or close off.

OPTICAL COMPARATOR: An electronic device used to inspect and measure the angular configuration of bevel characteristics on the cannula after grinding.

OVERALL LENGTH: The full length of the needle – from the point of the cannula to the farthest end of the hub; i.e.includes the part of cannula covered by the hub.

PARTICULATE MATTER: Any foreign substance contaminating a parenteral solution. These particles can be characterized according to their morphological and optical properties and evaluated under high magnification.

GLOSSARY OF TERMS


PATENTERAL INJECTION: Injection of substances into the body through any route other than via the alimentary canal; such as subcutaneous, intravenous, intramuscular or intrathecal injection.

PERMEABILITY: The property of stainless steel tubing which determines its relative influence in a magnetic field. This characteristic is often specified by customers depending on the end use of the product.

PENETRATION TESTS: Testing procedure used to measure the sharpness or penetration characteristics of a cannula when passed through a standard membrane. Spectra uses a Lloyd penetration tester for this purpose.

PROXIMAL END: The end of the cannula closest to the hub.

PYROGEN: A fever-inducing substance. Cleanliness in all phases of manufacturing and handling is essential to avoid pyrogenic product.

STERILE: Free from living micro-organisms. STUBS NEEDLE GUAGE: A system denoting O.D. size of a cannula. This is stated in numbers ranging from 7 through 35 – the larger the number is the smaller the needle is. See tubing specification chart.

STYLET: A solid rod with a handle. The tip is ground to fit the bevel of the needle through which it is run. This stylet, when introduced with the needle, helps prevent coring.

SUBCUTANEOUS: Under the skin.

SWAGING: 1) A method for crimping a hub onto a cannula by the use of pressure. 2) A process for shaping by compressing the O.D. of the cannula.

TROCAR: A three sided, sharp, pointed stylet fitted with a cannula to be inserted into a body cavity.

VENIPUNCTURE: The puncture of a vein with a needle.

WALL TYPES: The tubing wall is described by one of the following:• RW: Regular wall• TW: Thin wall• SPTW or XTW: Special or extra-thin wall

Hub Color Chart


EUROPEAN COLOR CHART

U.S. COLOR CHART

14G

14G

11G

11G

13G

13G

10G

10G

12G

12G

18G

18G

17G

17G 16G

15G

15G

22G

22G

21G

21G

20G

20G

19G

19G

26G

26G

25G

25G

24G

24G

16G

23G

23G

30G

30G

29G

29G

28G

28G

27G

27G

260 H Fordham Road | Wilmington, MA 01887978.657.0889 | www.spectramedical.com

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