BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visionix

    DI: 03664188000381 · Model: Nexy · LUNEAU TECHNOLOGY OPERATIONS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visionix
    Primary DI
    03664188000381
    Version / Model
    Nexy
    Company Name
    LUNEAU TECHNOLOGY OPERATIONS
    Labeler DUNS
    260432380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-08
    Public Version
    1
    Public Version Date
    2023-06-16
    Public Version Status
    New
    Public Device Record Key
    4bfae8fd-9c09-4d8c-a65b-a77be5890c3b

    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
    No
    Has Manufacturing Date
    Yes
    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

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 03664188000381