BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KDR DDR Primary U Arm

    DI: 00817100021268 · Model: Primary · KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    KDR DDR Primary U Arm
    Primary DI
    00817100021268
    Version / Model
    Primary
    Company Name
    KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
    Labeler DUNS
    080269345
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-30
    Public Version
    2
    Public Version Date
    2026-02-24
    Public Version Status
    Update
    Public Device Record Key
    079196fe-4752-4d3a-9ab0-11e900cbb1ba

    Device Description

    KDR Primary U-Arm System with Dynamic Digital Radiography

    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
    Yes
    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 00817100021268

    Premarket Submissions

    Submission Number Supplement Number
    K193225 000