Device Dossier

Needle, injector, medication/vaccine

Device Dossier for Needle, injector, medication/vaccine (Needle, injector, medication/vaccine, Class IIa, sponsor Embecta). ARTG record, intended…

Intended purpose

The pen needles are sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector. The pen injectors are themselves designed for the self-administration of a drug by a patient in the home setting. They may equally be used in a hospital but drug cartridges must not be shared between patients. The first and major application is the subcutaneous administration of insulin.

TGA Public Summary