Device Dossier
General-purpose syringe/needle
Device Dossier for General-purpose syringe/needle (General-purpose syringe/needle, Class IIa, sponsor YES Medical). ARTG record, intended purpose, GMDN…
- GMDN category: General-purpose syringe/needle
Intended purpose
A sterile empty device consisting of a calibrated barrel (cylinder) with plunger intended to be used with a needle for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may be used either manually or by a syringe pump. This is a single-use device.