BEUDAMED
    FDA Registration Active 🇺🇸 United States

    10mm Eye Sphere (Sterile)

    Reg #: 2518410 · FEI: 2518410 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GULDEN OPHTHALMICS
    Registration Number
    2518410
    FEI Number
    2518410
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    225 CADWALADER AVE.
    City
    Elkins Park
    State
    PA
    ZIP
    19027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972661

    Owner / Operator

    Firm Name
    GULDEN OPHTHALMICS INC
    Operator Number
    2518410
    Address
    225 CADWALADER AVE., --
    City
    Elkins Park
    State
    PA
    Postal Code
    19027
    Country
    US
    Correspondent
    SEAN T COCKLEY

    Products

    Device Name Product Code
    Implant, Eye Sphere HPZ
    Conformer, Ophthalmic HQN

    Proprietary Names

    10mm Eye Sphere (Sterile) Large Conformer (Sterile) Medium Conformer (Sterile) Medium Conformer with Holes (Sterile) Large Conformer with Holes (Sterile) Small Conformer with Holes (Sterile) 14mm Eye Sphere (Sterile) 12mm Eye Sphere (Sterile) 18mm Eye Sphere (Sterile) 22mm Eye Sphere (Sterile) Small Conformer (Sterile) 16mm Eye Sphere (Sterile) 20mm Eye Sphere (Sterile)

    Establishment Types

    Manufacture Medical Device