BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Getinge Assured Biological Indicators for Steam Sterilization

    Reg #: 3013667284 · FEI: 3013667284 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Mesa Laboratories Bozeman Manufacturing Facility (Zoot)
    Registration Number
    3013667284
    FEI Number
    3013667284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    625 Zoot Way
    City
    Bozeman
    State
    MT
    ZIP
    59718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K930682

    Owner / Operator

    Firm Name
    MESA LABORATORIES, INC.
    Operator Number
    1720309
    Address
    12100 WEST 6TH AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80228
    Country
    US

    Products

    Device Name Product Code
    Indicator, Biological Sterilization Process FRC

    Proprietary Names

    Getinge Assured Biological Indicators for Steam Sterilization EZTest Indicatore Biologico Auto-Contenuto EZTest Biological Indicator for Steam Sterilization

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device