BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TOPCON

    DI: 08034028770401 · Model: SOLOS · VISIA IMAGING SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    TOPCON
    Primary DI
    08034028770401
    Version / Model
    SOLOS
    Catalog Number
    42-0001417
    Company Name
    VISIA IMAGING SRL
    Labeler DUNS
    447668039
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-15
    Public Version
    1
    Public Version Date
    2022-09-23
    Public Version Status
    New
    Public Device Record Key
    dcfa266c-66d6-496e-835d-2ac9d7b6899b

    Device Description

    instrument intended for use by an optometric/ ophthalmic professional to measure spectacles and single lens properties.

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLM Instrument, Measuring, Lens, Ac-Powered

    GMDN Terms

    Code Name
    45753 Automated lensmeter

    Identifiers

    Type ID
    Primary 08034028770401