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GAUZE, paraffin, 15 cm x 2 m, sterile, roll

https://unicat.msf.org/cat/product/18499
STD SDRECOMP1P2

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.
M02030201 - Gauze impregnated without antiseptic
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
CT25
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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, paraffin

Definition

Large-meshed sterile compress, impregnated with fatty based substance. It does not stick to wounds, has no absorption capacity but facilitates the drainage of exudates.

Used to dress and protect large burn wounds and superficial wounds, not very exudative.

Synonym

paraffin gauze dressing, petrolatum woven gauze pad

Specifications

Technical specifications

  • Support: cotton or viscose knitted gauze, wide mesh (20 threads / cm²)
  • Impregnated with a neutral fatty substance:
    • paraffin, vaseline etc. (without Balsam of Peru, non medicated)
    • quantity: 175- 250 g/m²
  • Radio transparent
  • Sterile, for single use
  • Small size: 10 cm x 10 cm
  • Large size: 10 cm x 7 m or roll of 15 cm x 2 m

Packaging & Labelling

  • Compresses 10 x 10 cm: Each compress is packed in a disposable peel pack (plastic film and aluminium) allowing effective sterilization, safe handling, and storage until needed for use and facilitating proper aseptic presentation.
  • Large length compress
    • 10 cm x 7 m: one sterile dressing folded in a tray
    • 15 cm x 2 m: Individually packed in a sealed plastic or aluminium envelope

(Cf Introduction: Packaging and labelling)

Instructions for use

The large size is reserved for the dressing of extensive burns.

Once the package is opened, the paraffin gauze can no longer be considered as sterile.

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

Storage

  • Storage and transport: below 25°C, 60 % relative humidity
  • Do not freeze, Protect from sunlight
  • Store the packages flat

MSF requirements

Dressing for chronic wounds presenting healing problems.

Non adherent first layer for exudative wounds needing a secondary absorbent dressing.

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