Device Dossier

Scalpel, one-piece, single use

Device Dossier for Scalpel, one-piece, single use (Scalpel, one-piece, single use, Class IIa, sponsor Henry Schein Halas). ARTG record, intended purpose,…

Intended purpose

This device is a disposable, sterile, hand operated, single use surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) and is used by a dentist/oral health practitioner to manually incise or dissect intraoral tissue. The blade and handle is typically made of high grade stainless steel alloy.

TGA Public Summary