BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Orange Eye Shield

    Reg #: 2518410 · FEI: 2518410 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    1

    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

    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
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY

    Proprietary Names

    Orange Eye Shield Eye Shield Child (Bulk) Eye Shield Adult (dz) Eye Shield Foam (12pk) Eye Patch Shield Durette Plastic Goggles Dual Eye Shield Eye Shield Child (dz) Lasik Eye Guards (10pk) Dry Eye Lagophthalmos Kit Eye Shield Adult (Bulk)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device