Device Description : The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a se The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
Device Class :
Duns Number: 256900895
Premarket Exempt : No
Prescription Use : No
Device Description : The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indica The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer.
Device Class :
Duns Number: 256900895
Premarket Exempt : No
Prescription Use : No
Device Description : The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cyc The STERIZONE® VP4 Sterilizer currently offers a single preset sterilization cycle (Cycle 1) designed for the sterilization of a wide variety of loads consisting of general instruments, single, double or multi- channel flexible endoscopes, and rigid and semi-rigid channeled devices including single channel and double channel rigid endoscopes. The STERIZONE® VP4 Sterilizer uses dual sterilants, vaporized hydrogen peroxide (H2O2) and ozone (O3), in a multiphase process, and is the only dual-sterilant sterilizer cleared for use in the United States
Device Class : 2
Duns Number: 256900895
Premarket Exempt : No
Prescription Use : No
Device Description : The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 772 The 125-280 Solution™ product is 50% liquid hydrogen peroxide solution (CAS# 7722-84-1) provided in 280 mL bottles. The active ingredient is 50% H2O2 by weight and the inactive ingredients are water and stabilizing agents. The 125-280 Solution™ product is a stabilized analytical grade. The 125-280 Solution™ product is supplied in a bottle specially designed for use only in the STERIZONE® VP4 Sterilizer
Device Class : 2
Duns Number: 256900895
Premarket Exempt : No
Prescription Use : No
Device Description : Description of the test packs kit (TSO3 product code 44020):• Syringe with plung Description of the test packs kit (TSO3 product code 44020):• Syringe with plunger• Diffusion restrictor
Device Class : 2
Duns Number: 256900895
Premarket Exempt : No
Prescription Use : No