IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: part of fistula kit.
Product description: fistula scissor, sharp and strong
Used for fistula repair
Material: martensitic stainless steel (quenched, magnetic steel) composition of carbon 0.4, chromium 14%, silicon 0.5 % and manganese 0.4%
Method of sterilization: it should be able to withstand autoclave of steam sterilization.
Blades: curved
Length: 20cm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
For basic surgical operations.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address of supplier (manufacturer)
Symbols used according ISO 15223
CE Mark.
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: part of fistula kit.
Product description: fistula scissor, sharp and strong
Used for fistula repair
Material: martensitic stainless steel (quenched, magnetic steel) composition of carbon 0.4, chromium 14%, silicon 0.5 % and manganese 0.4%
Method of sterilization: it should be able to withstand autoclave of steam sterilization.
Blades: curved
Length: 20cm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals
Supplied with:
Manufacturer's instruction for use.
Instructions for use:
For basic surgical operations.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address of supplier (manufacturer)
Symbols used according ISO 15223
CE Mark.
Labelling as per regulations applied to the device. Shall include name of the device, name and address of the manufacturer, product code of manufacturers reference number etc.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $4.31 |
