BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    uDR

    DI: 00810030350071 · Model: uDR 780i · UIH TECHNOLOGIES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    uDR
    Primary DI
    00810030350071
    Version / Model
    uDR 780i
    Company Name
    UIH TECHNOLOGIES LLC
    Labeler DUNS
    117116896
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-26
    Public Version
    1
    Public Version Date
    2020-06-03
    Public Version Status
    New
    Public Device Record Key
    1f3b6611-c0ed-4a46-8b73-13b7ad5fb922

    Device Description

    The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.

    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
    KPR System, X-Ray, Stationary

    GMDN Terms

    Code Name
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00810030350071