Jimc o I ndustr iesManufacturer , Exporter & Importers of Surgical, Dental, Rehabilitation & Sterile...

Manufacturer , Exporter & Importers of

Surgical, Dental, Rehabilitation &

Sterile Disposable Instruments

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

Since 1965

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

INTRODUCTION

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.

DEVICE SPECIFICATION /DATA SHEET





Since 1965

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

invasive transient use

NUMBER OF DEVICES SPECIFICATION:- 07-

FAMILY:- DRESSING & TISSUE FORCEPS JUSTIFICATION:- SINGLE USE SURGICALLY INVASIVE TRANSIENT USE

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


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JimcoIndustries

Common / Usual NameArt NumbersClassification & relevant rule Intended use

(brief description of the devices)

Reference to Manufacturing

procedure/ MethodRule# Class Justification

6 Iia JI/CE/TW1Single Use Standard Dressing Tissue forceps

straight 13cm Made of stainless steel of Grade- 410

Iia

IIa

IIa

6

6

6

6

6

IIa

IIa

JI/CE/TW1

JI/CE/TW1

JI/CE/TW1

JI/CE/TW1

JI/CE/TW1

AD-100-14-D

AD-110-14-D

AD-158-20-D

AD-120-10-D

AD-140-10-D

Single Use Standard Dressing Tissue forceps straight 1x2 teeth 13cm

Made of stainless steel of Grade- 410

Single Use Standard Dressing Tissue forceps straight 16cm Made of stainless steel of Grade- 410

AD-171-15-D

AD-323-14-D

Single Use Adson tissue forceps 1x2 teeth straight 12cm Made of stainless steel of Grade- 410

Single Use Adson tissue forceps - straight- 12cm Made of stainless steel of Grade- 410

Single Use McIndoe dissecting forceps straight 15cm

Made of stainless steel of Grade- 410

Single Use Splinter plain forceps 12,5cm Made of stainless steel of Grade- 410

6 IIa JI/CE/TW1Single use Surgicallyinvasive transient use

holding of dressing,swabs,tissue;

insert/ablate foreign objects







retraction, grasping,or dissection of tissue

during surgicalprocedures. Holding and

moving of dressings,swabs. holding of dressing, swabs,

tissue; insert/ablate foreign objects

Single use Surgicallyinvasive transient use







STERILE STANDARD DRESSING TISSUE FORCE STRAIGHT 13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

6.1 Identification of the Devices

Family :- Material:- Hardness:‐ FORCEPS / AISI 410 / 40TO 44 HRC.

02 / 20 TO 30 Grm Appox Components:- Products Weight :-

AD-100-14-D Code:-

13.0cm / StraightSize:-

Disposable Sterile Metal InstrumentsCategory:-

Medical Device Type:-

IIAClass:-

6 Rule #:-

SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-

retraction, grasping, or dissection of tissue during surgical procedures. Holding and moving of dressings, swabs. holding of dressing, swabs, tissue; insert/ablate foreign objectsIntended Use:-

JI/CE/TW1Reference 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 DRESSING& TISSUE FORCEPS

0.09 to 0.15 %

1.0% maximum0.040% maximum0.030% maximum1.0% maximum11.5% to 13.5%1.0% maximum

GRADE-410

Detail of Material for Non Cutting Instruments

Jimco Code

AD-100-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Standard Dressing Tissue forceps straight 13cm

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


STERILE STANDARD DRESSING TISSUE FORCE STRAIGHT 1X2 13CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name


Family :- Material:- Hardness:‐ FORCEPS / AISI 410 / 40 TO 44 HRC.


AD-110-14-D Code:-

13.0cm / 1x2 StraightSize:-



IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410


Jimco Code

AD-110-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Standard Dressing Tissue forceps straight 1x2 teeth 13cm

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


STERILE STANDARD DRESSING TISSUE FORCE STRAIGHT 16 CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AD-158-20-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410


Jimco Code

AD-158-20-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Standard Dressing Tissue forceps straight 16cm

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


STERILE ADSON TISSUE FORCE STRAIGHT 12CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AD-120-10-D Code:-




IIAClass:-

6 Rule #:-


HOLDING OF DRESSING, SWABS,TISSUE INSERT/ABLATE FOREIGN OBJECTSIntended Use:-








JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410


Jimco Code

AD-120-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Adson tissue forceps - straight- 12cm

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


STERILE ADSON TISSUE FORCEPS 1X2 TEETH STRAIGHT 12CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AD-140-10-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410


Jimco Code

AD-140-10-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Adson tissue forceps 1x2 teeth straight 12cm

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


STERILE MCINDOE DISSECTING FORCEPS STRAIGHT 15CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AD-171-15-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5

Jimco Code

AD-171-15-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: McIndoe dissecting forceps 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



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410



STERILE SPLINTER PLAIN FORCEPS 12,5CM STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AD-323-14-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01



0.09 to 0.15 %


GRADE-410


Jimco Code

AD-323-14-D

Customer Code

Material Type

AISI 410

AISI 304

AISI 420

40-44

Rev

isio

n No

1

2

3

4

5

Date Description

Type-Single Use

Product: Splinter Plain Forceps 12.5cm

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

Jimc o I ndustr iesManufacturer , Exporter & Importers of Surgical, Dental, Rehabilitation & Sterile...

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