BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orbital Implant Sizer Kit

    DI: B091141700 · Model: 1 · Gulden Ophthalmics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Orbital Implant Sizer Kit
    Primary DI
    B091141700
    Version / Model
    1
    Catalog Number
    14170
    Company Name
    Gulden Ophthalmics Inc.
    Labeler DUNS
    002373249
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-28
    Public Version
    1
    Public Version Date
    2022-12-06
    Public Version Status
    New
    Public Device Record Key
    73aa4750-8621-497f-9196-e4de79f8cdb9

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    FTY Tape, Measuring, Rulers And Calipers

    GMDN Terms

    Code Name
    63398 Orbital sphere implant sizer

    Identifiers

    Type ID
    Primary B091141700