STERILE Technical sheet with composition and raw material ... · Manufacturer , Exporter &...

Manufacturer , Exporter & Importers of

Surgical, Dental, Rehabilitation &

Sterile Disposable Instruments

J imco I n d u s t r i e sR

Since 1965

INTRODUCTION

DEVICE SPECIFICATION /DATA SHEET

FAMILY SCISSORS SURGICALLY INVASIVE This document considers the requirements of technical documentation/ Device Master Record/ Product Specifications to satisfy the applicable requirements of Medical Device Directive number 93/42/EEC as amended up to Directive 2007/47/EC and the applicable clauses of ISO 13485: 2003, Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) and other applicable international standards.

4.0 Name and Address of the Manufacturer

4.1. Manufacturer: Jimco Industries,

4-Km, Aimen Abad Road,

Near Akbar Abad Chowk, Sialkot, Pakistan

4.2. Authorized Representative : Jimco Healthcare UK, 16 Devonshire Road, Middlesbrough TS5 6DP, London, UK.

5.0 Name and Address of the facilities

5.1 Manufacturer: Jimco Industries, (Same as above)

4-Km, Aimen Abad Road,

Near Akbar Abad Chowk, Sialkot, Pakistan

Technical Information/Specification # JI/CE/SDI/A

Part: First (A)

Revision level: 01

Copy # 01

Page. # 3

Since 1965Since 1965

JimcoIndustries





Since 1965

Class:- Rule #:- Justification IIA 6 Single Use Surgically

Invasive

Art Numbers Common / Usual Name Classification & relevant rule

Intended use (brief description of the

devices)

Reference to Manufacturing

procedure/ Method Rule# Class Justification

AB-065-09-D Metzenbaum scissors straight 16cm 6 IIa

Single use surgically invasive

cutting/ preparation of tissue

JI/CE/SCR3

AB-065-08-D Metzenbaum scissors curved 16cm 6 IIa



JI/CE/SCR3

AB-065-12-D Metzenbaum scissors curved 18cm 6 IIa



JI/CE/SCR3

AB-030-10-D Mayo scissors - straight- 15cm 6 IIa


Cutting hard tissue JI/CE/SCR3

AB-030-12-D Mayo scissors - straight- 17cm 6 IIa


Cutting hard tissue JI/CE/SCR3

AB-180-14-D Iris scissors sharp/sharp - straight - 11,5cm 6 IIa

single use surgically invasive

separates the anterior and posterior chambers of the eyeball

JI/CE/SCR3

AB-181-14-D Iris scissors sharp/sharp - curved - 11,5cm 6 IIa

single use surgically invasive

separates the anterior and posterior chambers of the eyeball

JI/CE/SCR3

NUMBER OF DEVICES SPECIFICATION:- 07-

FAMILY:- SCISSORS JUSTIFICATION:- SINGLE USE SURGICALLY INVASIVE

BRIEF INTENDED USE:- SEE BELOW COLUMN FOR EACH DECEIVE.


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JimcoIndustries


STERILE METZENBAUM SCISSORS STRAIGHT 16CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name

6.1 Identification of the Devices

Family :- Material:- Hardness:‐ Scissors / AISI 420 / 42 TO 46 HRC.

03 / 45 TO 55 Grm Appox Components:- Products Weight :-

AB-065-09-DCode:-

16.0cm / StraightSize:-

Disposable Sterile Metal InstrumentsCategory:-

Medical Device Type:-

IIAClass:-

6 Rule #:-

Single Use Surgically InvasiveJustification:-

CUTTING/ PREPARATION OF TISSUEIntended Use:-

JI/CE/SCR3Reference To Manufacturing Procedure:-

Ce /stainless Steel / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )

Gamma Radiation / Dose Level 2.5MRDSterilization Method:-

DuPont Tyvek Sterilization Reels width Size: 7.62 cmPACKING Material:-

Symbol To Be Used On Packing :-

ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644Harmonized Standards:-


JimcoIndustries





Since 1965

Image Of Products With &with out Coloring Identification Rings.

PEELS T E R I L E R REF LOT EUREPDO NOT USE IF THE

PACKAGING IS DAMAGEDSTORE INSTRUMENTPACK IN A DRY PLACE 2 0000


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Composi�on of Raw Material stainless steel .


JimcoIndustries




J imco I n d u s t r i e sTechnical Information/Specification # JI/CE/SDI/A

Part: First (A)

Revision level: 01

Copy # 01

Page. # 6 6.1 Identification of the DevicesTechnical Drawing & Technical Sheet With Composi�on And Raw Material .

PLANFAMILY SCISSORS

STERILE METZENBAUM SCISSORS CURVED 16CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-065-08-DCode:-

16.0cm / CURVEDSize:-



IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





6.1 Identification of the DevicesTechnical Information/Specification # JI/CE/SDI/A

Part: First (A)

Revision level: 01

Copy # 01

Page. # 7

AB-065-08-D

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Metzenbaum scissors curved 16cm

FDAApproved

ISO13485

9001-2003Certified

E-mail:[email protected]

Tolerance

xxx

All Dimensions in Millimeters.

5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director

Jimco Industries 4.KM Aminabad Road, Sialkot, Pakistan.

Phone: +92 52 3611253. Fax: +92 52 3611453



JimcoIndustries




J imco I n d u s t r i e s

Technical Drawing & Technical Sheet With Composi�onAnd Raw Material .


Part: First (A)

Revision level: 01

Copy # 01


PLANFAMILY SCISSORS


STERILE METZENBAUM SCISSORS STRAIGHT 18 CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-065-12-DCode:-

18.0cm / STRAIGHTSize:-



IIAClass:-

6 Rule #:-




CE/STAINLESS STEEL / Sign Of Single Use / On Customer RequestMarking:- ( SKU / LOT # )






JimcoIndustries





Since 1965






Part: First (A)

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JimcoIndustries





Part: First (A)

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Copy # 01


AB-065-12-D

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Metzenbaum scissors curved 18cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453


180.00

PLANFAMILY SCISSORS


STERILE MAYO SCISSORS - STRAIGHT - 15 CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-030-10-DCode:-




IIAClass:-

6 Rule #:-


Cutting Hard TissueIntended Use:-








JimcoIndustries





Since 1965






Part: First (A)

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JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



Jimco Code

AB-030-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Mayo scissors - straight- 15cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453

PLANFAMILY SCISSORS

STERILE MAYO SCISSORS - STRAIGHT - 17 CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-030-12-DCode:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965






Part: First (A)

Revision level: 01

Copy # 01

Page. # 13


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



Jimco Code

AB-030-12-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Mayo scissors - straight- 17cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453

PLANFAMILY SCISSORS

170.00

STERILE IRIS SCISSORS SHARP/SHARP - STRAIGHT - 11,5CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-180-14-DCode:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965






Part: First (A)

Revision level: 01

Copy # 01

Page. # 15

Jimco Code

AB-180-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Iris scissors sharp/sharp - straight - 11,5cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453


JimcoIndustries




J imco I n d u s t r i e s

Technical Drawing & Technical Sheet With Composi�onAnd Raw Material .


Part: First (A)

Revision level: 01

Copy # 01



PLANFAMILY SCISSORS


STERILE IRIS SCISSORS SHARP/SHARP - CURVED - 11,5CM STAINLESS STEEL DISPOSABLE METAL STERILE INSTRUMENTS

Common / Usual Name



AB-181-14-DCode:-

11.5cm / CURVEDSize:-



IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965






Part: First (A)

Revision level: 01

Copy # 01

Page. # 17

Jimco Code

AB-181-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420 42-46 Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Iris scissors sharp/sharp - curved - 11,5cm

FDAApproved

ISO13485

9001-2003Certified


Tolerance

xxx


5.00

xx 0.50-0.30

x 0.25-0.15

Drawn By:

Approved By

Q.A:Departmet

Managing Director


Phone: +92 52 3611253. Fax: +92 52 3611453


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



PLANFAMILY SCISSORS

STERILE Technical sheet with composition and raw material ... · Manufacturer , Exporter &...

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