BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FLUOROspeed

    DI: 04540217061716 · Model: 566-23000-01 · SHIMADZU CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FLUOROspeed
    Primary DI
    04540217061716
    Version / Model
    566-23000-01
    Company Name
    SHIMADZU CORPORATION
    Labeler DUNS
    690558747
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-24
    Public Version
    1
    Public Version Date
    2019-11-01
    Public Version Status
    New
    Public Device Record Key
    8652fb0c-b3a6-49f0-aa1d-4008d4fb0b01

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37679 Stationary general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 04540217061716

    Premarket Submissions

    Submission Number Supplement Number
    K191877 000