BEUDAMED
    FDA Registration Active 🇺🇸 United States

    V-Vial

    Reg #: 3005579300 · FEI: 3005579300 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    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

    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
    System, Applicator, Radionuclide, Manual IWJ

    Proprietary Names

    V-Vial SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIROS D-Vial Prep Set SIROS Delivery Set SIR-Spheres V-Vial

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device