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COMPRESS, abdominal, 45x45 cm, 4 layers, 17 threads, sterile

https://unicat.msf.org/cat/product/18502
STD SDRECOMP4A4

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.
M0201030201 - Laparotomy cotton gauzes, with 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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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, abdominal

Definition

Sterile thick and large compress, fitted with a loop and an X-ray contrast strip sewn in and stabilizing seams. Laparotomy swabs are intended for direct use in the operating room. They are used for holding and retaining organs and tissues as well as for haemostasis and absorbing body fluids during surgery. They are intended for short term use (up to 24 hours)

Synonym

laparotomy sponge

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, woven, 100 % pre-washed cotton
  • Does not contain any active substance
  • 17 - 20 threads/cm²
  • Weight: 23 - 27 g/m²
  • Size: unfolded = 45 cm x 45 cm +/- 1 cm, folded = 11.5 x 11.5 cm +/- 5mm
  • 4 or 6 stitched layers
  • X-ray detectable strip (PVC + barium sulfate)
  • Turned in, overcast edges, ensuring high strength and no free thread
  • Coloured loop for holding
  • Sterile, for single use

Packaging & Labelling

Presentation in double packaging either 2 peelable pockets or a Pasteur folded crepe paper and a peelable pouch. Some packages may contain a label for tracability.

(Cf Introduction: Packaging and labelling)

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