BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rotating Anode X-ray Tube Assembly

    DI: 04580274410317 · Model: DRX-4634HC · CANON ELECTRON TUBES & DEVICES CO. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rotating Anode X-ray Tube Assembly
    Primary DI
    04580274410317
    Version / Model
    DRX-4634HC
    Company Name
    CANON ELECTRON TUBES & DEVICES CO. LTD.
    Labeler DUNS
    696985530
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-23
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    395515b2-63f7-4b0f-901e-0724978da103

    Device Description

    Diagnostic X-ray Tube Housing Assembly

    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
    Yes
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

    GMDN Terms

    Code Name
    35618 X-ray tube housing assembly, diagnostic

    Identifiers

    Type ID
    Primary 04580274410317