IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor."
Intended use: Used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Product description:
Rectangular plastic sheet, used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Material: Opaque of translucent plastic (PVC)
Size: approx. 100 x 100cm.
Thickness: 100-200 microns'
Waterproof.
Single use and non-sterile.
Hygienically clean for hospital use.
Instructions for use:
Used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Material: Opaque of translucent plastic (PVC)
After the first use it must be disposed in waste container, collected and destroyed.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Packaging: One (1) plastic draw sheet in a plastic bag.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
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.
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 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor."
Intended use: Used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Product description:
Rectangular plastic sheet, used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Material: Opaque of translucent plastic (PVC)
Size: approx. 100 x 100cm.
Thickness: 100-200 microns'
Waterproof.
Single use and non-sterile.
Hygienically clean for hospital use.
Instructions for use:
Used to protect equipment from liquid soiling, non-sterile and multiple use. Also, is used tod to protect the examination, delivery, operating tables and/of bed mattresses from soiling.
Material: Opaque of translucent plastic (PVC)
After the first use it must be disposed in waste container, collected and destroyed.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Packaging: One (1) plastic draw sheet in a plastic bag.
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
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.
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 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.70 |
