BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sirtex Wilmington LLC

    Reg #: 3005579300 · FEI: 3005579300 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    Sirtex Wilmington LLC
    Registration Number
    3005579300
    FEI Number
    3005579300
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    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 Inc.
    Operator Number
    9047689
    Address
    300 Unicorn Park Dr., 2nd Fl.
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US
    Correspondent
    Jeffrey Cyr

    Products

    Device Name Product Code
    Shield, Protective, Personnel KPY
    Microspheres Radionuclide NAW
    Holder, Syringe, Lead IWR
    System, Applicator, Radionuclide, Manual IWJ
    Embolization Agent, Vascular QVG
    Shield, Vial IWW

    Proprietary Names

    SIR-Spheres Delivery Box SIROS Delivery Dome SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres Syringe Shield SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIR-Spheres V-Vial SIROS Delivery Set V-Vial LAVA Mixing Kit LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit LAVA Liquid Embolic System (LES) LAVA Liquid Embolic System (LES) Kit SIROS D-Vial Prep Set SIR-Spheres V-Vial Holder

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device