BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    A-scan probe

    DI: 04987669200070 · Model: 14610-0006 · NIDEK CO.,LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    A-scan probe
    Primary DI
    04987669200070
    Version / Model
    14610-0006
    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
    6552b03a-de53-4856-9387-31417e95733b

    Device Description

    It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.

    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
    ITX Transducer, Ultrasonic, Diagnostic
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 04987669200070

    Customer Contacts

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