BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UR-NEXT4KH

    DI: 04907034602186 · Model: 1921070130 · TEAC MANUFACTURING SOLUTIONS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UR-NEXT4KH
    Primary DI
    04907034602186
    Version / Model
    1921070130
    Company Name
    TEAC MANUFACTURING SOLUTIONS CORPORATION
    Labeler DUNS
    693002487
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-02
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    8899eee1-839a-4ae8-b508-249c9a9c10b0

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    LMB Device, Digital Image Storage, Radiological

    GMDN Terms

    Code Name
    63260 Medical video image recorder

    Identifiers

    Type ID
    Primary 04907034602186