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(Goulian dermatome) BLADES, non sterile, s.u.

https://unicat.msf.org/cat/product/14006
STD ESURDERG101

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.
V0103 - Blades, single-use - not included in other classes
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
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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Dermatome, Goulian

Definition

A hand-held manual surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade.

Synonym

Weck dermatome

Specifications

Technical specifications

BLADE HOLDER with gripping handle

  • Austenitic steel
  • Length: 180 mm

GRAFTING TEMPLATES

  • 3 different ones: 0.2, 0.25 and 0.3 mm (graft's thickness, dept gauge)

BLADE

  • martensitic stainless steel
  • single edge blade
  • non sterile (sterilize before use)
  • for single use
  • box of 5 blades supplied with the dermatome

Instructions for use

Single use blades are to be ordered separately. The blades have to be sterilized before use. Do not use blades intended for other dermatomes.

The functioning of all parts of the dermatome must be meticulously tested before each use as it determines the quality of the graft.

The dermatome must be sterilized by steam after each use. Assemble and dismantle the components with great care, without forcing.

Waste management

Immediately after use, dispose of the soiled blade into a sealed container. Get rid of in a sharp pit.

(Cf Public Health Engineering In Precarious Situations, MSF, 2010, Chapter 6)

MSF requirements

The Goulian dermatome is smaller and easier to use than the Watson/Humby model and it allows to take smaller grafts.

It can be used on a daily basis when smaller grafts have to be performed, procedures which do not justify the use of a expensive powered dermatome and a mesher.

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