BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3nethra

    DI: 08908007754037 · Model: neo control box · FORUS HEALTH PRIVATE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3nethra
    Primary DI
    08908007754037
    Version / Model
    neo control box
    Company Name
    FORUS HEALTH PRIVATE LIMITED
    Labeler DUNS
    864213893
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-31
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    25ed3d04-a470-4514-b582-c1d5b9de5ac0

    Device Description

    3nethra neo is a contact device to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    PJZ Camera, Ophthalmic, General-Use

    GMDN Terms

    Code Name
    10551 Ophthalmic fundus camera

    Identifiers

    Type ID
    Primary 08908007754037