Page. # 3 INTODUCTION FAMILY SCISSOS SUGICALLY INVASIVE This document considers the requirements of technical documentation/ Device Master ecord/ 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 egulation (QS) and other applicable international standards. 4.0 Name and Address of the Manufacturer 4.1. Manufacturer:, 4-Km, Aimen Abad oad, Near Akbar Abad Chowk, Sialkot, Pakistan 4.2. Authorized epresentative : Healthcare UK, 16 Devonshire oad, Middlesbrough TS5 6DP, London, UK. 5.0 Name and Address of the facilities 5.1 Manufacturer:, (Same as above) 4-Km, Aimen Abad oad, Near Akbar Abad Chowk, Sialkot, Pakistan
Page. # 4 NUMBE OF DEVICES SPECIFICATION:- 07- FAMILY:- SCISSOS JUSTIFICATION:- SINGLE USE SUGICALLY INVASIVE BIEF INTENDED USE:- SEE BELOW COLUMN FO EACH DECEIVE. Class:- ule #:- Justification IIA 6 Single Use Surgically Invasive Art Numbers Common / Usual Name Classification & relevant rule AB-065-09-D AB-065-08-D AB-065-12-D AB-030-10-D AB-030-12-D AB-180-14-D AB-181-14-D Metzenbaum scissors straight 16cm Metzenbaum scissors curved 16cm Metzenbaum scissors curved 18cm Mayo scissors - straight- 15cm Mayo scissors - straight- 17cm Iris scissors sharp/sharp - straight - 11,5cm Iris scissors sharp/sharp - curved - 11,5cm ule# Class Justification 6 IIa 6 IIa 6 IIa 6 IIa 6 IIa 6 IIa 6 IIa Single use surgically invasive Single use surgically invasive Single use surgically invasive Single use surgically invasive Single use surgically invasive single use surgically invasive single use surgically invasive Intended use (brief description of the devices) cutting/ preparation of tissue cutting/ preparation of tissue cutting/ preparation of tissue Cutting hard tissue Cutting hard tissue separates the anterior and posterior chambers of the eyeball separates the anterior and posterior chambers of the eyeball eference to Manufacturing procedure/ Method JI/CE/SC3 JI/CE/SC3 JI/CE/SC3 JI/CE/SC3 JI/CE/SC3 JI/CE/SC3 JI/CE/SC3
Page. # 5 Common / Usual Name STEILE METZENBAUM SCISSOS STAIGHT 16CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 45 TO 55 Grm Appox Code:- AB-065-09-D Size:- 16.0cm / Straight Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- CUTTING/ PEPAATION OF TISSUE eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Page. # 6 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS Composi on of aw Material stainless steel.
Page. # 7 Common / Usual Name STEILE METZENBAUM SCISSOS CUVED 16CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 45 TO 55 Grm Appox Code:- AB-065-08-D Size:- 16.0cm / CUVED Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- CUTTING/ PEPAATION OF TISSUE eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Technical Drawing evision & level: Technical 01 Page. # Sheet 8 With Composi on And aw Material. Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS Composi on of aw Material stainless steel. AB-065-08-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Metzenbaum scissors curved 16cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A:Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director
Page. # 9 Common / Usual Name STEILE METZENBAUM SCISSOS STAIGHT 18 CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 50 TO 60 Grm Appox Code:- AB-065-12-D Size:- 18.0cm / STAIGHT Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- CUTTING/ PEPAATION OF TISSUE eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- CE/STAINLESS STEEL / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Harmonized Standards:- Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Page. # 10 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS 180.00 Composi on of aw Material stainless steel. AB-065-12-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Metzenbaum scissors curved 18cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A:Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director
Page. # 11 Common / Usual Name STEILE MAYO SCISSOS - STAIGHT - 15 CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 35 TO 45 HC. Components:- 03 / Products Weight :- 40 TO 50 Grm Appox Code:- AB-030-10-D Size:- 15.0cm / Straight Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- Cutting Hard Tissue eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 Harmonized Standards:- ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Page. # 12 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS Composi on of aw Material stainless steel. Code Customer Code AB-030-10-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Mayo scissors - straight- 15cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A: Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director
Page. # 13 Common / Usual Name STEILE MAYO SCISSOS - STAIGHT - 17 CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 50 TO 60 Grm Appox Code:- AB-030-12-D Size:- 17.0cm / Straight Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- Cutting Hard Tissue eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 Harmonized Standards:- ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Page. # 14 Technical Drawing & Technical Sheet With Composi on And aw Material. 170.00 PLAN FAMILY SCISSOS Composi on of aw Material stainless steel. Code Customer Code AB-030-12-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Mayo scissors - straight- 17cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A: Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director
Page. # 15 Common / Usual Name STEILE IIS SCISSOS SHAP/SHAP - STAIGHT - 11,5CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 15 TO 25 Grm Appox Code:- AB-180-14-D Size:- 11.5cm / Straight Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- Cutting Hard Tissue eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 Harmonized Standards:- ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Technical Drawing evision & level: Technical 01 Page. # Sheet 16 With Composi on And aw Material. Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS Composi on of aw Material stainless steel. Code Customer Code AB-180-14-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Iris scissors sharp/sharp - straight - 11,5cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A:Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director
Page. # 17 Common / Usual Name STEILE IIS SCISSOS SHAP/SHAP - CUVED - 11,5CM STAINLESS STEEL DISPOSABLE METAL STEILE INSTUMENTS Family :- Scissors / Material:- AISI 420 / Hardness: 42 TO 46 HC. Components:- 03 / Products Weight :- 15 TO 25 Grm Appox Code:- AB-181-14-D Size:- 11.5cm / CUVED Category:- Disposable Sterile Metal Instruments Type:- Medical Device Class:- IIA ule #:- 6 Justification:- Single Use Surgically Invasive Intended Use:- Cutting Hard Tissue eference To Manufacturing Procedure:- JI/CE/SC3 Marking:- Ce /stainless Steel / Sign Of Single Use / ( SKU / LOT # On Customer equest) Sterilization Method:- Gamma adiation / Dose Level 2.5MD PACKING Material:- DuPont Tyvek Sterilization eels width Size: 7.62 cm Symbol To Be Used On Packing :- PEEL Image Of Products With &with out Coloring Identification ings. DO NOT USE IF THE STOE INSTUMENT S T E I L E EF LOT EU EP PACKAGING IS DAMAGED PACK IN A DY PLACE 2 0000 Harmonized Standards:- ISO 7153-1, EN ISO 11737-1:2006, ISO 14644 ISO 7153-1,EN ISO 11737-1:2006, ISO 14644
Page. # 18 Technical Drawing & Technical Sheet With Composi on And aw Material. PLAN FAMILY SCISSOS Composi on of aw Material stainless steel. Code Customer Code AB-181-14-D Material Type AISI 410 AISI 304 AISI 420 42-46 evision No 1 2 3 4 5 Date Description Type-Single Use Product: Iris scissors sharp/sharp - curved - 11,5cm FDA Approved 4.KM Aminabad oad, Sialkot, Pakistan. Phone: +92 52 3611253. Fax: +92 52 3611453 ISO 13485 9001-2003 Certified E-mail:info@jimcoind.com All Dimensions in Millimeters. Tolerance xxx 5.00 Drawn By: Q.A:Departmet xx 0.50-0.30 Approved By x 0.25-0.15 Managing Director