BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Peds Pack

    Reg #: 2518410 · FEI: 2518410 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    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
    Device, Fixation, Ac-Powered, Ophthalmic HPL

    Proprietary Names

    Peds Pack Color Fixation Sticks Fixation Sticks (4pk) Flashing Fixation Sticks (2pk) Flashing Butterfly Fixation Stick Pediatric Fixation Wand Face Fixation Sticks (3pk) Pediatric Fixation Sticks (3pk)

    Establishment Types

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