BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit

    Reg #: 9710358 · FEI: 3003428886 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sirtex Medical Pty Ltd
    Registration Number
    9710358
    FEI Number
    3003428886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Shop 6, 207 Pacific Highway
    City
    St Leonards New South Wales
    Country
    AU

    Regulatory Submissions

    PMA Number
    P220020

    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

    US Agent

    Business Name
    Sirtex Medical, Inc.
    Contact Name
    Jeffrey Cyr
    Address
    300 Unicorn Park Drive, 2nd Floor
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US
    Email
    [email protected]
    Phone
    781 7213889

    Products

    Device Name Product Code
    Embolization Agent, Vascular QVG

    Proprietary Names

    LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198