Device Dossier

SBAGeneral - Surgical procedure kit, general-purpose, single-use, medicated

Device Dossier for SBAGeneral - Surgical procedure kit, general-purpose, single-use, medicated (Surgical procedure kit, general-purpose, single-use,…

Intended purpose

A pre-packaged kit/pack that contains all the various components, instruments and dressings (invasive and/or non-invasive) necessary to perform general surgical 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