Intended purpose of use: used to separate the margins of an abdominal incision typically during deep of extensive surgery, to expose of access organs for examination of intervention.
Product description:
Abdominal self-retaining Gosset retractor with 1 fixed arm and 1 mobile arm. The instrument has wire-like blades that hold the abdomen open and an additional third blade that is tensioned using a series of eye holes of notches.
3 blades including two sliding blades and a central blade and central blade used to retract skin, fatty tissue, muscles, peritoneum and bladder area after the abdominal incision to expose the operative field.
Material: Martensitic steel (quenched, magnetic steel).
composition: 18 to 20% chromium; 8 to 10% nickel.
Self retaining.
Sliding system enabling a variable opening (maximum 110mm).
Mobile, adjustable Central blade: 57 x 60mm.
Fenestrated lateral blades: approx. depth 58mm.
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 after the incision to expose the operative field.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Primary packaging: Unit of use.
One (1) retractor in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol), if applicable.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate of equivalent harmonised symbol.
Information for handling, if applicable (of equivalent harmonised symbol).
Symbols used according ISO 15223.
Over packaging: Packaging unit.
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.
Product description:
Abdominal self-retaining Gosset retractor with 1 fixed arm and 1 mobile arm. The instrument has wire-like blades that hold the abdomen open and an additional third blade that is tensioned using a series of eye holes of notches.
3 blades including two sliding blades and a central blade and central blade used to retract skin, fatty tissue, muscles, peritoneum and bladder area after the abdominal incision to expose the operative field.
Material: Martensitic steel (quenched, magnetic steel).
composition: 18 to 20% chromium; 8 to 10% nickel.
Self retaining.
Sliding system enabling a variable opening (maximum 110mm).
Mobile, adjustable Central blade: 57 x 60mm.
Fenestrated lateral blades: approx. depth 58mm.
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 after the incision to expose the operative field.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Packaging & Labelling:
Primary packaging: Unit of use.
One (1) retractor in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol), if applicable.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate of equivalent harmonised symbol.
Information for handling, if applicable (of equivalent harmonised symbol).
Symbols used according ISO 15223.
Over packaging: Packaging unit.
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 | $27.50 |
