Product description:
Dressing material used for holding a compress in place of to cover of isolate a wound.
Material: Absorbent gauze, 100 % cotton.
Bleached, purified textile, plain weave.
Gauze bandage with selvage.
Non-elastic, non-adhesive, non-detectable by X-ray.
Thread count: Warp 12 threads / cm, weft 8 threads / cm.
Weight: Approx. 27.5g / m2.
Width: approx. 8 cm.
Length: approx. 400 cm.
Non-sterile.
Single use.
Hygienically packed for medical use.
Shelf life to be included
Instructions for use:
Dressing material used for holding a compress in place of to cover of isolate a wound.
Gauze bandage with selvedge must be selected to avoid remaining threads on wounds, burns etc.
The size has been chosen as being the most commonly used.
Safety process:
The gauze bandage is for single use only.
Collect and destroy by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use. Storage conditions, disposal instructions etc
Packaging and labelling:
Primary packaging: Unit of use.
One (1) gauze bandage in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) gauze bandages in a plastic bag.
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:
Must comply with the following standards (must be compliant as per the latest revisions of the standards):
BS EN 14079:2003 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency
of equivalent standards such as USP
Environmental requirements:
ISO 14001
Dressing material used for holding a compress in place of to cover of isolate a wound.
Material: Absorbent gauze, 100 % cotton.
Bleached, purified textile, plain weave.
Gauze bandage with selvage.
Non-elastic, non-adhesive, non-detectable by X-ray.
Thread count: Warp 12 threads / cm, weft 8 threads / cm.
Weight: Approx. 27.5g / m2.
Width: approx. 8 cm.
Length: approx. 400 cm.
Non-sterile.
Single use.
Hygienically packed for medical use.
Shelf life to be included
Instructions for use:
Dressing material used for holding a compress in place of to cover of isolate a wound.
Gauze bandage with selvedge must be selected to avoid remaining threads on wounds, burns etc.
The size has been chosen as being the most commonly used.
Safety process:
The gauze bandage is for single use only.
Collect and destroy by incineration in a controlled environment.
Supplied with:
Manufacturer's instruction for use. Storage conditions, disposal instructions etc
Packaging and labelling:
Primary packaging: Unit of use.
One (1) gauze bandage in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) gauze bandages in a plastic bag.
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:
Must comply with the following standards (must be compliant as per the latest revisions of the standards):
BS EN 14079:2003 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency
of equivalent standards such as USP
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 5 | $1.07 |
| Pack of 10 | $2.12 |
| Pack of 12 | $2.54 |
| Pack of 15 | $3.17 |
