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ROOT ELEVATOR, APICAL, n°3, 325-13-03

https://unicat.msf.org/cat/product/13809
STD ESUDELEV53-

Valid Article

Former Code(s): -X
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.
L1505 - Odontostomatology levers, reusable
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.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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ROOT ELEVATOR, APICAL

Definition

A hand-held dental instrument used as a lever during the extraction of a tooth or retained roots. It is a one-piece instrument with a strong but slender blade at the distal working end. It is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments.

Specifications

3 different shapes:

  • curved nº 2: left side
  • curved nº 3: right side
  • straight nº 4

Instructions for use

The instruments are delivered “non-sterile”.

They mustbe used by trained, qualified personnel who respect the recommendations given in the instructions for use.

Maintenance

General recommendations

  • It is recommended to reprocess instruments as soon as possible after use
  • Prohibit the use of sodium hypochlorite to avoid corrosion pitting on instruments
  • For all metal appliances, it is recommended to use anti-corrosion cleaning and disinfection agents.
  • Do not use fixing products or hot water (> 40°C) which will cause the proteins to fix and influence the cleaning result.
  • Follow the instructions and respect the concentrations and immersion times given by the manufacturer (excessive concentration can lead to corrosion or other defects on the devices)
  • Perform a visual inspection to verify the cleanliness and integrity of the instruments. If necessary, repeat the reprocessing process until the instrument is visibly clean.
  • It is very important to check all surgical instruments before use for visible wear or damage.

Due to the design of the product and the materials used, no limits on the maximum number of processing cycles achievable can be specified. The lifespan of medical devices is determined by their function and careful handling.

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