IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used during urological, gynaecological and general surgeries to retract internal organs and tissues to enhance the view of the surgical field
Product description: Self retaining retractor, three Blade Retractor For Increased Surgical View. Used to retract the abdominal wall and viscera to provide good exposure during a laparotomy
Suprapubic abdominal retractor with locking mechanism and compass (self-holding).
Consists of three parts: 1 compass (frame) + 2 lateral blades + 1 central blade
The compass is a support with hinged arms.
Fenestrated lateral blades: approx. 35 x 70 mm.
Solid centre blade: approx. 45 x 80 mm.
Maximum wound opening: approx. 180 mm.
Material: Martensitic steel (quenched, magnetic steel). composition: From 0.42% to 0.55% carbon; From 12% to 15% chromium; From 0.45% to 0.9% molybdenum.
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 1400
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used during urological, gynaecological and general surgeries to retract internal organs and tissues to enhance the view of the surgical field
Product description: Self retaining retractor, three Blade Retractor For Increased Surgical View. Used to retract the abdominal wall and viscera to provide good exposure during a laparotomy
Suprapubic abdominal retractor with locking mechanism and compass (self-holding).
Consists of three parts: 1 compass (frame) + 2 lateral blades + 1 central blade
The compass is a support with hinged arms.
Fenestrated lateral blades: approx. 35 x 70 mm.
Solid centre blade: approx. 45 x 80 mm.
Maximum wound opening: approx. 180 mm.
Material: Martensitic steel (quenched, magnetic steel). composition: From 0.42% to 0.55% carbon; From 12% to 15% chromium; From 0.45% to 0.9% molybdenum.
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 1400
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $55.00 |
