BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESSILOR

    DI: 03664188000435 · Model: Retina 800 · LUNEAU TECHNOLOGY OPERATIONS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESSILOR
    Primary DI
    03664188000435
    Version / Model
    Retina 800
    Catalog Number
    RET1IN
    Company Name
    LUNEAU TECHNOLOGY OPERATIONS
    Labeler DUNS
    260432380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-02
    Public Version
    2
    Public Version Date
    2025-01-15
    Public Version Status
    Update
    Public Device Record Key
    4354ac9c-5d8b-4390-91f7-a90c7da56f77

    Device Description

    Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent.

    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 03664188000435