BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pachymetry probe (45° fixed type)

    DI: 04987669200049 · Model: 14130-0006 · NIDEK CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pachymetry probe (45° fixed type)
    Primary DI
    04987669200049
    Version / Model
    14130-0006
    Company Name
    NIDEK CO.,LTD.
    Labeler DUNS
    690635461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-10
    Public Version
    1
    Public Version Date
    2023-07-18
    Public Version Status
    New
    Public Device Record Key
    0db10477-28bb-423d-b2ff-fa8e4e965be0

    Device Description

    It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 04987669200049

    Customer Contacts

    Phone
    1-800-223-9044
    Email
    [email protected]