BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANAEYES OCT for system linkage

    DI: 03615020000496 · Model: ANAEYES OCT · ESSILOR INTERNATIONAL
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANAEYES OCT for system linkage
    Primary DI
    03615020000496
    Version / Model
    ANAEYES OCT
    Company Name
    ESSILOR INTERNATIONAL
    Labeler DUNS
    277373213
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-18
    Public Version
    1
    Public Version Date
    2021-02-26
    Public Version Status
    New
    Public Device Record Key
    f65e990d-693e-42e8-bbc9-0f245ff7a815

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NFJ System, Image Management, Ophthalmic
    HKI Camera, Ophthalmic, Ac-Powered
    OBO Tomography, Optical Coherence

    GMDN Terms

    Code Name
    38683 Camera application software

    Identifiers

    Type ID
    Primary 03615020000496