BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIAGNOSTIC X-RAY SYSTEM KALARE

    DI: 04987670100116 · Model: DREX-KL80 · CANON MEDICAL SYSTEMS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIAGNOSTIC X-RAY SYSTEM KALARE
    Primary DI
    04987670100116
    Version / Model
    DREX-KL80
    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
    cbd1263a-25cd-49b0-be89-f4bcf088c41d

    Device Description

    DIAGNOSTIC X-RAY SYSTEM KALARE

    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

    GMDN Terms

    Code Name
    40658 Fluoroscopy/angiography table, powered

    Identifiers

    Type ID
    Primary 04987670100116

    Customer Contacts

    Phone
    +1-8004211968
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133553 000