IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Used in superficial surgery to retract skin, fatty tissues and muscles after the incision
Product description: A handheld retractor that is a solid piece of stainless steel with one angled blade at each end. Each blade is smooth, blunt, and also has a slight upward lip at the end
Material: Austenitic stainless steel (non-quenched, non-magnetic steel) composition: 18% to 20% chromium; 8 to 10% nickel.
Retractor with handle, double-ended with angled blade.
One end 24 x 16mm, the other end 28 x 16mm.
Supplied in pairs.
Length: approx. 150mm.
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:
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address and 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 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
ISO 7151 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: Used in superficial surgery to retract skin, fatty tissues and muscles after the incision
Product description: A handheld retractor that is a solid piece of stainless steel with one angled blade at each end. Each blade is smooth, blunt, and also has a slight upward lip at the end
Material: Austenitic stainless steel (non-quenched, non-magnetic steel) composition: 18% to 20% chromium; 8 to 10% nickel.
Retractor with handle, double-ended with angled blade.
One end 24 x 16mm, the other end 28 x 16mm.
Supplied in pairs.
Length: approx. 150mm.
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:
To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address and 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 Medical Devices- Application of risk management to medical devices
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel
ISO 7151 Surgical instruments -- Non-cutting, articulated instruments -- General requirements and test methods
ISO 13402 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 17664 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $4.02 |
