BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIS Corporation

    Reg #: 3007412809 · FEI: 3007412809 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    62
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    STERIS Corporation
    Registration Number
    3007412809
    FEI Number
    3007412809
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11457 MELROSE AVE
    City
    FRANKLIN PARK
    State
    IL
    ZIP
    60131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110253

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Indicator, Biological Sterilization Process FRC

    Proprietary Names

    SteriScan Reusable Test Pack without Counter (3306NC) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) VERIFY SixCess MF4 STEAM Emulating Indicator (FP-CFE) SteriScan Reusable Test Pack with Counter (3306) (FP-CFE) Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD) Celerity 20 STEAM Biological Indicator (LCB063) (PC-UMXD) Celerity 20 STEAM Process Challenge Device for Dynamic Air Removal Cycles (LCB064, LCB065) (PC-UMXD) Mesa ProChem SSW Steam Integrator (FP-CM, HP-CM) SteriScan Steam Integrator (1100) (FP-CM, HP-CM) HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM, HP-CM) MCKESSON INTEGRATORS (FP-CM, HP-CM) SPS INTEGRATORS (FP-CM, HP-CM) Patterson Type 5 (FP-CM, HP-CM) K Dental Indicators (FP-CM, HP-CM) SPS ENSURE (FP-CM, HP-CM) SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM, HP-CM) SPS Henry Schein Integrator (FP-CM, HP-CM) Hu-Friedy Steam Sterilization Integrator (FP-CM, HP-CM) SPS EMULATING INDICATORS (FP-CM, HP-CM) VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE) Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB056) (FP-MF, HP-MF) VERIFY All-In-One Steam Reusable Test Pack with Tag (LCB057) (FP-MF, HP-MF) SteriScan Six Emulating Indicator (2200 and 2201) (FP-CFE) SteriScan Reusable Test Pack (5500) (FP-CFE) Celerity Xtend 10 Assembly (LCB054) (PC-CFE) Informer Med Steam PCD (FP-CFE) SteriScan Reusable Test Pack (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE) VERIFY All-In-One Bowie Dick Indicator Strips (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB040) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE) SteriScan Reusable Bowie Dick Test Pack (5500) (FP-CFE) SteriScan Reusable Test Pack (3300NC) (FP-CFE) VERIFY STEAM INTEGRATING INDICATOR 5CM (PCC067) (FP-MF, HP-MF) SteriScan Reusable Extended Cycle Test Pack (4400) (FP-CFE) SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM,HP-CM) McKesson Steam Integrator (FP-CM,HP-CM) Henry Schein Integrator (FP-CM,HP-CM) K-Dental Indicators (FP-CM,HP-CM) SPS EMULATING INDICATORS (FP-CM,HP-CM) SPS INTEGRATORS (FP-CM,HP-CM) SPS ENSURE (FP-CM,HP-CM) Patterson Type 5 (FP-CM,HP-CM) HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM) MCKESSON STERILIZATION INTEGRATOR (FP-CM,HP-CM) SPS Henry Schein Integrator (FP-CM,HP-CM) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB036) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB037) (FP-MF, HP-MF) VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB035) (FP-MF, HP-MF) SteriScan Steam Integrator (1100EMA) Celerity HP Chemical Indicator Challenge Pack (PCC083) (PC-UMXD) MCKESSON INTEGRATORS (FP-MF, HP-MF) SPS EMULATING INDICATORS (FP-MF, HP-MF) SPS Henry Schein Integrator (FP-MF, HP-MF) Hu-Friedy Steam Sterilization Integrator (FP-MF, HP-MF) SPS ENSURE (FP-MF, HP-MF) K Dental Indicators (FP-MF, HP-MF) Patterson Type 5 (FP-MF, HP-MF) SPS INTEGRATORS (FP-MF, HP-MF) HENRY SCHEIN MAXITEST INTEGRATORS (FP-MF, HP-MF)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)