BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIR-Spheres

    Reg #: 3005579300 · FEI: 3005579300 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sirtex Wilmington LLC
    Registration Number
    3005579300
    FEI Number
    3005579300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    16 Upton Drive Unit 2-4
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    PMA Number
    P990065

    Owner / Operator

    Firm Name
    Sirtex Medical Pty Ltd
    Operator Number
    9047689
    Address
    Shop 6, 207 Pacific Highway
    City
    St Leonards
    State
    New South Wales
    Postal Code
    2065
    Country
    AU

    Products

    Device Name Product Code
    Microspheres Radionuclide NAW

    Proprietary Names

    SIR-Spheres SIR-Spheres Select SIR-Spheres Select Y-90 resin microspheres SIR-Spheres microspheres

    Establishment Types

    Manufacture Medical Device