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    FDA UDI In Commercial Distribution 🇺🇸 United States

    INTERVENTIONAL ANGIOGRAPHY SYSTEM

    DI: 04987670100192 · Model: INFX-8000C · CANON MEDICAL SYSTEMS CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INTERVENTIONAL ANGIOGRAPHY SYSTEM
    Primary DI
    04987670100192
    Version / Model
    INFX-8000C
    Company Name
    CANON MEDICAL SYSTEMS CORPORATION
    Labeler DUNS
    690575113
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1b5a6abd-8e67-4507-be2f-b10936980050

    Device Description

    INTERVENTIONAL ANGIOGRAPHY SYSTEM

    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
    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
    JAA System, x-ray, fluoroscopic, image-intensified
    OWB Interventional fluoroscopic x-ray system

    GMDN Terms

    Code Name
    37623 Stationary angiographic x-ray system, digital

    Identifiers

    Type ID
    Primary 04987670100192

    Customer Contacts

    Phone
    +1-8004211968
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152697 000