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COMPRESS, NON WOVEN, 4 plies, 7.5 cm, non sterile

https://unicat.msf.org/intros#21930
https://unicat.msf.org/cat/product/18495
STD SDRECOMN7N-

Valid Article

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).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
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.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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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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