Device Dossier
Cartridge-accepting autoinjector, mechanical
Device Dossier for Cartridge-accepting autoinjector, mechanical (Cartridge-accepting autoinjector, mechanical, Class IIa, sponsor SciGen). ARTG record,…
- GMDN category: Cartridge-accepting autoinjector, mechanical
- Sponsor: SciGen
Intended purpose
A portable, hand-held, mechanical pen device, designed to accept a pharmaceutical containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle (not included). The cartridge is inserted into the device and a dial on the device is operated for dosing via a spring-loaded mechanism; the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.