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TRONCULAR NEEDLE, 30G (0.30 x 16 mm), sterile, s.u.

https://unicat.msf.org/cat/product/13821
STD ESUDNEET3D1

Valid Article

Former Code(s): -X
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.
A010601 - Carpule needles
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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TRONCULAR NEEDLE

Definition

A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics.

Synonym

Dental needle

Specifications

Quality Standards Comment

ISO 7885: 2010: Dentistry - Sterile injection needles for single use (confirmed in 2020)

Technical specifications

  • Luer connection
  • 3-beveled tip
  • stainless steel
  • 30G
  • short: length 16 mm
  • sterile, for single use

Instructions for use

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

Precautions for Use

Immediately after use, dispose of the soiled needle into a sharps container.

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