Device Dossier
Insulin syringe, retractable-needle
Device Dossier for Insulin syringe, retractable-needle (Insulin syringe, retractable-needle, Class IIa, sponsor Pacific Health Care). ARTG record,…
- GMDN category: Insulin syringe, retractable-needle
Intended purpose
A sterile device consisting of a calibrated barrel (cylinder) with plunger, with an attached needle (sometimes shielded), intended to be used to administer an injection of insulin to a patient subcutaneously. It is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients. After use, the needle is fully retracted into the plunger, providing protection against needle sticks and rendering the device unusable. This is a single-use device