BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BVI1689 (EP1) - Extend™ Synthetic Implants (0.2mm X 2mm)

    Reg #: 1643817 · FEI: 1643817 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC
    Registration Number
    1643817
    FEI Number
    1643817
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1435 ISOMEDIX PLACE
    City
    EL PASO
    State
    TX
    ZIP
    79936
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013613

    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
    Plug, Punctum LZU

    Proprietary Names

    BVI1689 (EP1) - Extend™ Synthetic Implants (0.2mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.3mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.4mm X 2mm BVI1689 (EP1) - Extend™ Synthetic Implants (0.5mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (Variety Pack)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)