SURGICAL HOOD, non-woven, s.u.

STD ELINHOOS1--

Valid Article

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.
T0207 - Caps and headwear (excluding personal protective equipment - ppe)
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.
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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SURGICAL HOOD, non-woven

Definition

A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to completely cover their hair in order to protect the patient from micro-particles falling into the surgical field during a surgical intervention.

This is intended for projects in which internal fixation is being performed. It is a single-use device.

Specifications

Technical specifications

  • Non-woven fabric: 25 g/m2
  • Air permeable
  • Complete head coverage leaving only the face uncovered
  • Wide ties, for closure around the neck
  • Colour: green or blue
  • Universal size
  • Non sterile, for single use

Packaging & Labelling

Box of 50 or 100 pieces

MSF requirements

The wearing of a surgical hood by the operating theatre staff is part of the minimal criteria when performing internal fixation in surgical orthopaedic programmes.

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