Intended purpose of use: non-medicated, sterile gauze made from woven material and primarily designed to absorb fluids for medical purposes and wound care.
Product description:
Gauze compress, surgical folding, i.e. no free threads apparent after folding of when the first outside fold is opened.
Material: Absorbent gauze, 100% cotton.
Components: Bleached, purified textile, plain weave.
Compress gauze folded.
Non-detectable by X-ray.
Thread count warp: 95 to 105 threads/dm, weft 66 to 74 threads/dm.
Weight: 23g/m2.
Type of gauze: 17 threads/cm2 (grammage 23g/m2).
Number of folds (thickness): 12.
Width: approx. 10cm.
Length: approx. 10cm.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas of ionising radiation.
Shelf life
Instructions for use:
Dressing material used for cleaning wounds, disinfecting healthy skin, protecting wounds, etc. Shall indicate storage conditions, disposal instructions etc.
Sterile gauze compress:
17 threads, 12 folds (same quality and same standard as the non-sterile gauze compress), reserved for emergencies and surgical departments,
until a reliable sterilisation system is set up; the size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling: Shall be as per regulations applied to the device
Primary packaging: Unit of use.
Five (5) gauze compresses in an individual sterilised peel pouch
Secondary packaging: Protected unit.
One (1) box of 4 packs of 5 gauze compresses.
Symbols used according ISO 15223
CE mark with notified body number
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 Is device
Safety & product Standards:
Must comply with the following standards (as per the latest revisions of the standards):
BS EN 14079 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze of as per pharmacopoeia specifications for bleached cotton gauze
EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Product description:
Gauze compress, surgical folding, i.e. no free threads apparent after folding of when the first outside fold is opened.
Material: Absorbent gauze, 100% cotton.
Components: Bleached, purified textile, plain weave.
Compress gauze folded.
Non-detectable by X-ray.
Thread count warp: 95 to 105 threads/dm, weft 66 to 74 threads/dm.
Weight: 23g/m2.
Type of gauze: 17 threads/cm2 (grammage 23g/m2).
Number of folds (thickness): 12.
Width: approx. 10cm.
Length: approx. 10cm.
Sterile and single use.
Initial sterilisation method: Ethylene oxide gas of ionising radiation.
Shelf life
Instructions for use:
Dressing material used for cleaning wounds, disinfecting healthy skin, protecting wounds, etc. Shall indicate storage conditions, disposal instructions etc.
Sterile gauze compress:
17 threads, 12 folds (same quality and same standard as the non-sterile gauze compress), reserved for emergencies and surgical departments,
until a reliable sterilisation system is set up; the size has been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling: Shall be as per regulations applied to the device
Primary packaging: Unit of use.
Five (5) gauze compresses in an individual sterilised peel pouch
Secondary packaging: Protected unit.
One (1) box of 4 packs of 5 gauze compresses.
Symbols used according ISO 15223
CE mark with notified body number
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 Is device
Safety & product Standards:
Must comply with the following standards (as per the latest revisions of the standards):
BS EN 14079 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze of as per pharmacopoeia specifications for bleached cotton gauze
EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
| Pack Size | Avg. Price |
|---|---|
| Pack of 5 | $0.23 |
| Pack of 20 | $1.08 |
| Pack of 50 | $2.33 |
