BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SteriScan Reusable Bowie Dick Test Pack (5500) (FP-CFE)

    Reg #: 3007412809 · FEI: 3007412809 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STERIS Corporation
    Registration Number
    3007412809
    FEI Number
    3007412809
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11457 MELROSE AVE
    City
    FRANKLIN PARK
    State
    IL
    ZIP
    60131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120592

    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

    Proprietary Names

    SteriScan Reusable Bowie Dick Test Pack (5500) (FP-CFE) VERIFY All-In-One Bowie Dick Indicator Strips (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB040) (FP-CFE)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device