BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TUR Irrigation Set

    Reg #: 1416980 · FEI: 1416980 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BAXTER HEALTHCARE CORPORATION
    Registration Number
    1416980
    FEI Number
    1416980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25212 W. ILLINOIS ROUTE 120
    City
    ROUND LAKE
    State
    IL
    ZIP
    60073
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960787

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Arthroscope HRX
    System, Irrigation, Urological LJH

    Proprietary Names

    TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Arthromatic Uromatic Interlink

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility