Product description:
Stainless steel wire basket used as support for sterilizing surgical instruments.
Material : austenitic stainless steel (non-quenched, non-magnetic steel).AISI 316L stainless steel
Rectangular basket, rounded not soldered corners.
Close mesh netting (4.5x4.5 mm).
Tilting handles.
Dimensions: approx. 400 x 200 x 90 mm.
Instructions for use:
Stainless steel wired basket used as support for sterilizing surgical instruments.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) sterilization basket in a protective plastic bag with manufacturer's instruction for user in English.
Labelling :
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Symbols used according ISO 15223
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.
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:
EN 10088-1, Stainless steels — Part _1: List of stainless steels
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
Not use PVC polymer
Stainless steel wire basket used as support for sterilizing surgical instruments.
Material : austenitic stainless steel (non-quenched, non-magnetic steel).AISI 316L stainless steel
Rectangular basket, rounded not soldered corners.
Close mesh netting (4.5x4.5 mm).
Tilting handles.
Dimensions: approx. 400 x 200 x 90 mm.
Instructions for use:
Stainless steel wired basket used as support for sterilizing surgical instruments.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
One (1) sterilization basket in a protective plastic bag with manufacturer's instruction for user in English.
Labelling :
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Symbols used according ISO 15223
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.
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:
EN 10088-1, Stainless steels — Part _1: List of stainless steels
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $56.54 |
