COMPRESS, NON WOVEN, 4 plies, 7.5 cm, non sterile
STD
SDRECOMN7N-
Valid Article
Account code:
60210
HS Code:
300590
Last Updated on:
07/11/2024, 18:29:34
Former
Code(s):
-X
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
M0202010102 - Non-woven folded gauzes, without x-ray detectable thread, non-sterile
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
COMPRESS, NON-WOVEN, non sterile
Definition
A non-medicated, non-sterile compress made from non-woven material and primarily designed to absorb fluids for medical purposes.
It is used to cover/clean wounds and absorb their exudates, to apply topical medications or disinfect healthy skin prior to a venipuncture or an injection.
It produces less lint, is less adherent and less abrasive compared to basic woven gauze pads.
Specifications
Quality standards
- EN 1644-1, 1997, Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
- EN 1644-2, 2000, Test methods for nonwoven compresses for medical use Part 2: Finished compresses
Technical specifications
- Synthetic material:
- viscose: 67% (± 3 %)
- polyester: 33% (± 3%)
- latex-free
- Weight: ± 40 g / m² +/- 10%
- Size folded: 7.5 cm x 7.5 cm
- Absorbency: ± 11 g of water / g of material (minimum required by the norm: 9 g of water / g material)
- Thickness: 4 plies
- Radio transparent
- Non sterile, for single use
Packaging & Labelling
Packed per 50 or 100, primary package = sulphite paper or plastic
Instructions for use
Do not use for aseptic care.
For medical care where sterile compresses are required, it is better to use compresses that are sterilized by an industrial process rather than non-sterile compresses that are sterilized in the field. This is important for quality, hygiene, time and cost reasons.
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