BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Protech3048 (TM) - Hex Wrench

    Reg #: 2030624 · FEI: 3000206435 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2030624
    FEI Number
    3000206435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43425 Business Park Dr
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    PMA Number
    P910023

    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
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pulse Generator, Permanent, Implantable NVZ

    Proprietary Names

    Protech3048 (TM) - Hex Wrench Protech3048 (TM) - IS-1 Receptacle Plus Protech3048 (TM) - Lead Cap (IS1/DF1/SJ4) Protech3048 (TM) - Torque Driver Protech3048 (TM) - IS4/DF4 Port Plug Accessory Kit Protech3048 (TM) - DF-1 Receptacle Plug

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)