BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Automated Perimeter

    DI: 05903293141168 · Model: PTS 925BY · OPTOPOL TECHNOLOGY SP Z O O
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Automated Perimeter
    Primary DI
    05903293141168
    Version / Model
    PTS 925BY
    Catalog Number
    765-002
    Company Name
    OPTOPOL TECHNOLOGY SP Z O O
    Labeler DUNS
    522052554
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-09
    Public Version
    3
    Public Version Date
    2023-07-12
    Public Version Status
    Update
    Public Device Record Key
    efe1e354-11e2-43fc-8af5-69ec3a7d7a18

    Device Description

    The PTS 925BY automated perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HPT Perimeter, Automatic, Ac-Powered

    GMDN Terms

    Code Name
    16918 Perimeter, automatic

    Identifiers

    Type ID
    Primary 05903293141168