Device Dossier

SANAngiophy - Angiographic kit

Device Dossier for SANAngiophy - Angiographic kit (Angiographic kit, Class III, sponsor Medline International Two). ARTG record, intended purpose, GMDN…

Intended purpose

A pre-packaged kit/pack that contains all the various components, instruments and dressings (invasive and/or non-invasive) necessary to perform angiography procedures. Packs are single use, sterile and ready to use according to the customer requirements.

Functional description

Same as intended purpose, includes various components as per hospital requirement and may contain Class III components such as, not limited to, guide wires, catheters, incise medicated drapes.

TGA Public Summary