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COMPRESS, GAUZE, 10 cm, 12 plies, 17 threads, sterile

https://unicat.msf.org/cat/product/18501
STD SDRECOMP1S-

Valid Article

Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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.
M0201020101 - Cotton gauzes, folded, without x-ray detectable thread, 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 sterile
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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GAUZE COMPRESS, woven, sterile

Definition

A non-medicated, sterile dressing item in the form of a patch (also referred to as a sponge) made from woven material and primarily designed to absorb fluids for medical purposes. It is used in wound care, making up of dressings and for any procedure requiring a sterile compress.

Specifications

Quality standards

EN 14079, 2003, Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

Technical specifications

  • Absorbent gauze, 100 % cotton
  • 17 threads/cm²
  • Weight: 23 g/m²
  • Thickness: 12 plies
  • Surgical folding with turned in edges (so that no free thread is apparent after folding or when the first outside fold is opened)
  • Sterile, for single use
  • Dimensions:
    • Large
      • Folded: 10 cm x 10 cm
      • Unfolded: 30 cm (± 0,5 cm) X 40 cm (± 0,5 cm)
    • Small
      • Folded: 5 cm x 5 cm
      • Unfolded: 20 cm (± 0,5 cm) X 20 cm (± 0,5 cm)

Packaging & Labelling

Packed in a disposable peel pack allowing effective sterilization, safe handling, and storage of all pouched items until needed for use and facilitating proper aseptic presentation of the material.

  • per 5 for the 10 cm compresses SDRECOMP1S-
  • individually for the 5 cm compresses SDRECOMP5S-

(Cf Introduction: Packaging and labelling)

Instructions for use

Compresses intended for sterile medical and surgical care.

It is better to use sterile compresses 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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