Search Results

The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121° Celsius saturated steam process for 18 minutes

The Series 2100 clinical autoclaves by Prestige Medical are Model numbers 2100 07 (extended body) and 2100 06 (standard body). Both are 120 volt autoclaves, which have a 18 minute sterilization cycle at 121°C. The height of the extended body autoclave is slightly greater than that of the standard body (420mm versus 335mm). The devices have substantially the same technological characteristics as the devices cleared under K910789 and K900432, and the identical materials, design, composition and function as the products currently marketed under K910789 and K900432. The slight modification reflected in the subject devices is that the "plug and pintle," which performed air bleed, pressure indicator and excess pressure relief functions, has been replaced by three separate components, each of which fulfills one of the functions formerly performed by the plug and pintle. The three separate components are: an air bleed device; a pressure rise indicator in the lid of the product; and a gasket blow-out slot through which a sealing gasket may extrude if necessary.