BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX

    Reg #: 2245304 · FEI: 2245304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    2245304
    FEI Number
    2245304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Apollo Dr
    City
    WHIPPANY
    State
    NJ
    ZIP
    07981
    Country
    US

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Instruments, Surgical, Cardiovascular DWS

    Proprietary Names

    Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX Merit1383 (TM) - Contamination Sleeve Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Worley Slitter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)