BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMAGEnet 6 OPHTHALMIC DATA SYSTEM

    DI: 04562123288582 · Model: IMAGEnet 6 · TOPCON CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMAGEnet 6 OPHTHALMIC DATA SYSTEM
    Primary DI
    04562123288582
    Version / Model
    IMAGEnet 6
    Company Name
    TOPCON CORPORATION
    Labeler DUNS
    690542881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-07
    Public Version
    7
    Public Version Date
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    f00e9ec8-aad8-4bfc-9120-ce866193e983

    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
    Yes
    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
    HKI Camera, Ophthalmic, Ac-Powered
    OBO Tomography, Optical Coherence
    NFJ System, image management, ophthalmic

    GMDN Terms

    Code Name
    63764 Ophthalmology PACS software

    Identifiers

    Type ID
    Primary 04562123288582