BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEM Biover Clamps

    Reg #: 1062741 · FEI: 3000302153 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
    Registration Number
    1062741
    FEI Number
    3000302153
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    439 Industrial Ln
    City
    BIRMINGHAM
    State
    AL
    ZIP
    35211
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221843

    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
    Clamp, Vascular DXC

    Proprietary Names

    GEM Biover Clamps

    Establishment Types

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