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SAFETY SCALPEL, s.u., sterile, nº 11

https://unicat.msf.org/cat/product/87587
STD SSURSCAL11S

Valid Article

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.
V010101 - Scalpels with safety systems, single-use
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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SAFETY SCALPEL, disposable

Definition

A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. It comes with a safety mechanism which significantly reduces puncture and cut wound hazards.

Disposable surgical instrument

Synonym

retractable scalpel

Specifications

The blade No.11 is an elongated triangular blade sharpened along the hypotenuse edge with a strong pointed tip making it ideal for stab incisions needed when lancing an abscess or inserting a chest drain. The blade No.11 is also used for other small incisions.

The blade No.15 blade has a small curved cutting edge and is the most popular blade shape ideal for making short and precise incisions. It is used in a variety of surgical procedures including the excision of a skin lesion

Image

Technical specifications

  • Plastic handle #3
  • With stainless steel blade
  • Protective cartridge completely covers the blade
  • Retractable blade
    • temporary forward lock position preventing uncontrolled retraction
    • passing position
    • rear permanent lock to be engaged prior to final disposal in a sharps container
  • Sterile, for single use

Packaging & Labelling

Each scalpel is packed in a disposable peel pack allowing safe handling, and storage until needed for use and facilitating proper aseptic presentation. Often packed per 10.

Instructions for use

The scalpel blade is pushed out of the transparent blade protector by means of a pushing mechanism prior to its use.
After use, the pusher pulls the blade back until the safety mechanism at the back end of the scalpel handle locks it into position, making reuse impossible. The blade is now irreversibly retracted in the blade protector and no longer poses a hazard to staff.

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