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VAGINAL PESSARY, open ring, 64 x 12 mm

https://unicat.msf.org/cat/product/49452
STD SMSUVPESR64

Valid Article

Former Code(s): SMSUZBE0068
Single patient multiple 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.
U089005 - Pessaries
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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VAGINAL PESSARY, open ring

Definition

A device made of soft plastics designed for insertion into the vagina to hold the uterus in place. It is shaped as an open ring and is available in different sizes. It has to be fitted for each woman individually. It is used either as a permanent or temporary treatment of uterine prolapse.

Specifications

  • shape: open ring
  • material: flexible PVC or silicone
  • thickness of the ring: +/- 12 mm
  • ​diameter of the ring: 3 sizes are selected:
    • +/- 64 mm
    • +/- 71 mm
    • +/- 80 mm
    • exact sizes depend according the manufacturer

Instructions for use

Pessaries can be removed daily, weekly, or monthly, (minimum every 3 to 6 months) at patients' discretion, for washing with regular soap and water. Ring pessaries can be removed or left in place for intercourse.

MSF requirements

Common pessary for a first to second degree prolapse.

Insertion is eased with the folding action of the ring

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