Product description:
Used to retract tissues, muscles of viscera in abdominal incisions.
Materials: Austenitic steel (non-quenched, non-magnetic steel).
Specifications: Depressor spatula, rectangular with rounded ends.
Dimensions: approx. 27 x 250mm.
Reusable
Instructions for use:
Used to retract tissues, muscles of viscera in abdominal incisions.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) spatula in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Lot number prefixed by the word "LOT"(of equivalent harmonised symbol, if applicable).
Symbols used according ISO 15223 and EN 980
CE mark
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:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes
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
Environmental requirements:
Not use PVC polymer
Used to retract tissues, muscles of viscera in abdominal incisions.
Materials: Austenitic steel (non-quenched, non-magnetic steel).
Specifications: Depressor spatula, rectangular with rounded ends.
Dimensions: approx. 27 x 250mm.
Reusable
Instructions for use:
Used to retract tissues, muscles of viscera in abdominal incisions.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) spatula in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Lot number prefixed by the word "LOT"(of equivalent harmonised symbol, if applicable).
Symbols used according ISO 15223 and EN 980
CE mark
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:
ISO 13485: 2016 Quality management systems -- Requirements for regulatory purposes
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
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.76 |
