Device Dossier
Unclassified
Device Dossier for Unclassified (Unclassified, Class IIa, sponsor Olympus). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Unclassified
Intended purpose
Disposable tip and drape are attached to a re-usable handle that is battery powered. By pressing a button on the reusable handle, energy is delivered to the tip which heats up instantly. The heated tip is applied to a Smart piston, causing it to close during incus attachment in ENT surgery. The handle is wrapped with the drape so that it can be reused without extensive cleaning.