Device Dossier
Scalpel, one-piece, single use
Device Dossier for Scalpel, one-piece, single use (Scalpel, one-piece, single use, Class IIa, sponsor Alphatec). ARTG record, intended purpose, GMDN…
- GMDN category: Scalpel, one-piece, single use
Intended purpose
A sterile, hand-operated surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by a physician to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.