FDA-Device2023-08-09Class II
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Scican Ltd.
Hazard
The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Sold states
US Nationwide Distribution and in the country of Canada
Affected count
19 units
Manufactured in
100-1440 Don Mills Rd, N/A, North York, N/A, Canada
Products
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2285-2023Don't want to check this manually?
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