J im co In dustr ie sR - Gima

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:- 08-

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/FCP2Single Use PEAN Forceps 14cm Curved

Made of stainless steel of Grade- 410

Iia

IIa

IIa

6

6

6

6

6

IIa

IIa

JI/CE/FCP2

6 IIa Single use Surgicallyinvasive transient use

Single use Surgicallyinvasive transient use





Single use Surgicallyinvasive transient useAC-134-01-D

AC-134-03-D

AC-134-05-D

AC-127-02-D

AC-141-12-D

AC-142-12-D

AE-136-14-D

Single Use PEAN Forceps 16cm Curved Made of stainless steel of Grade- 410

Single Use PEAN Forceps 18cm Curved Made of stainless steel of Grade- 410

Single Use SPENCER WELLS 13cm Straight Made of stainless steel of Grade- 410

Single Use Mosquito Forceps 12.5cm Straight


Single Use Mosquito Forceps 12.5cm Curved


Single Use FOERSTER sponge forceps 25cm Straight


JI/CE/FCP2

JI/CE/FCP2

JI/CE/FCP2

JI/CE/FCP2

JI/CE/FCP2

Holding tissue/ artery during surgery


Holding Sponge, swabs

Holding tissue/ artery /blood vessel during surgery




CA-212-12-DSingle Use Pozzi Uterine tenaculum forceps 25cmSTRAIGHT Made of stainless steel of Grade- 410

6 IIa Single use Surgicallyinvasive transient use JI/CE/FCP2

Manipulation of the cervix or uterus


STERILE PEAN Forceps 14cm Curved STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name

6.1 Identification of the Devices

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

02 / 35 TO 45 Grm Appox Components:- Products Weight :-

AC-134-01-D Code:-

14.0cm / CurvedSize:-

Disposable Sterile Metal InstrumentsCategory:-

Medical Device Type:-

IIAClass:-

6 Rule #:-

SINGLE USE SURGICALLY INVASIVE TRANSIENT USEJustification:-

Holding tissue/ artery / blood vessel during surgery Intended Use:-

JI/CE/FCP2Reference 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: 10.16 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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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 .

Jimco Code

AC-134-01-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: Pean forceps curved 14cm

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

PLANFORCEPS

Composi�on of Raw Material stainless steel .

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



Common / Usual Name


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


AC-134-03-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 5

Jimco Code

AC-134-03-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


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


0.09 to 0.15 %


GRADE-410



JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS



Common / Usual Name




AC-134-05-D Code:-




IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 9


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS

Jimco Code

AC-134-05-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


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


0.09 to 0.15 %


GRADE-410



STERILE SPENCER WELLS 13CM STRAIGHT STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name


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


AC-127-02-D Code:-

13.0cm / STRAIGHTSize:-



IIAClass:-

6 Rule #:-


Holding tissue/ artery during surgery Intended Use:-








JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 11

Jimco Code

AC-127-02-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: Spencer wells forceps straight 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


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS


0.09 to 0.15 %


GRADE-410



STERILE MOSQUITO FORCEPS 12.5CM STRAIGHT STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Common / Usual Name




AC-141-12-D Code:-

12.5cm / STRAIGHTSize:-



IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 13

Jimco Code

AC-141-12-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: Haemostatic Halstead-Mosquito forceps-straight-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


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS


0.09 to 0.15 %


GRADE-410



Common / Usual Name




AC-142-12-D Code:-

12.5cm / CURVEDSize:-



IIAClass:-

6 Rule #:-










JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 15

STERILE MOSQUITO FORCEPS 12.5CM CURVED STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)

Jimco Code

AC-142-12-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: Haemostatic Halstead-Mosquito forceps-curved-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


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS


0.09 to 0.15 %


GRADE-410



Common / Usual Name




AC-136-14-D Code:-

25.0 cm / STRAIGHTSize:-



IIAClass:-

6 Rule #:-


Holding Sponge, swabs Intended Use:-








JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 17

STERILE FOERSTER SPONGE FORCEPS 25CM STRAIGHT STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS


0.09 to 0.15 %


GRADE-410


Jimco Code

AE-136-14-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: Foerster polypus forceps 25cm

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

ManagingDirector

Jimco Industries 4.KM Aminabad Road, Sialkot,

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

3611453


Common / Usual Name




CA-212-12-D Code:-

25.0 cm / STRAIGHTSize:-



IIAClass:-

6 Rule #:-


Manipulation of the cervix or uterusIntended Use:-








JimcoIndustries





Since 1965





Part: First (A)

Revision level: 01

Copy # 01

Page. # 19

STERILE POZZI UTERINE TENACULUM FORCEPS 25CM STRAIGHT STAINLESS STEEL - (DISPOSABLE METAL STERILE INSTRUMENTS)


JimcoIndustries





Part: First (A)

Revision level: 01

Copy # 01


PLANFORCEPS


0.09 to 0.15 %


GRADE-410


Jimco Code

CA-212-12

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: Pozzi Tenaculum Forcep 25.5cm

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

J im co In dustr ie sR - Gima

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