BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Eckardt temporary keratoprosthesis, Ø 8 mm, 2.5 mm depth

    DI: 08717872004570 · Model: 1285.5 · D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eckardt temporary keratoprosthesis, Ø 8 mm, 2.5 mm depth
    Primary DI
    08717872004570
    Version / Model
    1285.5
    Catalog Number
    1285.5
    Company Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Labeler DUNS
    407522184
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    5
    Public Version Date
    2022-01-13
    Public Version Status
    Update
    Public Device Record Key
    a6bb976d-d6fb-43cd-a0ba-862b2f993100
    Distribution End Date
    2021-04-13

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MLP Keratoprosthesis, Temporary Implant, Surgical Use

    GMDN Terms

    Code Name
    36054 Therapeutic contact lens

    Identifiers

    Type ID
    Primary 08717872004570