DENTAL SYRINGE, for cartridge 1.8 ml, 330-50-18

STD ESUDSYDE1--

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.
A020203 - Cartridge syringes
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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DENTAL SYRINGE

Definition

Syringe for dental anaesthesia

A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle.

Specifications

  • Large see-through window
  • Lateral loading
  • Self-aspirating as the result of a drop-in pressure
  • Can be used with all commercially available 1.8 ml cartridges
  • With thumb ring
  • Autoclavable

Quality Standards Comment

ISO 9997: 2020: Dentistry - Cartridge syringes

MSF requirements

Cartridge syringe with aspiration in order to prevent any risk of accidental intravascular injection.

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