Device Dossier

Sterilizer, moist heat, wrapped goods

Device Dossier for Sterilizer, moist heat, wrapped goods (Sterilizer, moist heat, wrapped goods, Class IIb, sponsor Henry Schein Halas). ARTG record,…

Intended purpose

The STATIM range of Autoclaves are table-top autoclaves that are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable wrapped or unwrapped, solid or hollow medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process. The non-cassette format is also intended to sterilize porous loads. The STATIM family of Autoclaves are intended to be used by trained health-care professionals including, but not limited to, dentists, nurses, doctors, infection control and re-processing personnel

TGA Public Summary