BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NON-MYDRIATIC RETINAL CAMERA TRC-NW400

    DI: 04571130283022 · Model: TRC-NW400 · TOPCON CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NON-MYDRIATIC RETINAL CAMERA TRC-NW400
    Primary DI
    04571130283022
    Version / Model
    TRC-NW400
    Company Name
    TOPCON CORPORATION
    Labeler DUNS
    690542881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-28
    Public Version
    1
    Public Version Date
    2022-02-07
    Public Version Status
    New
    Public Device Record Key
    f3b5822e-33d2-42f8-903f-1e7a5c4889d1

    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 04571130283022