BEUDAMED
    FDA Registration Active 🇺🇸 United States

    USGI MEDICAL

    Reg #: 3004447686 · FEI: 3004447686 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    6

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    Registration Details

    Registration Name
    USGI MEDICAL
    Registration Number
    3004447686
    FEI Number
    3004447686
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1140 CALLE CORDILLERA
    City
    SAN CLEMENTE
    State
    CA
    ZIP
    92673
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102916

    Owner / Operator

    Firm Name
    USGI MEDICAL
    Operator Number
    9060300
    Address
    1140 CALLE CORDILLERA, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Tom - Palmer

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Laparoscope, Gynecologic (And Accessories) HET
    Staple, Implantable GDW
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Endoscopic Contamination Prevention Sheath ODB
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    g-Cath Tissue Anchor G-LIX TISSUE GRASPER g-Prox EZ Endoscopic Grasper SHAPELOCK TRANSPORT

    Establishment Types

    Manufacture Medical Device