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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Skan C Mobile C - Arm X - Ray system

    DI: 08904269405519 · Model: F303-000187-2 · SKANRAY TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Skan C Mobile C - Arm X - Ray system
    Primary DI
    08904269405519
    Version / Model
    F303-000187-2
    Company Name
    SKANRAY TECHNOLOGIES LIMITED
    Labeler DUNS
    863358955
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-21
    Public Version
    2
    Public Version Date
    2022-01-19
    Public Version Status
    Update
    Public Device Record Key
    76c05ccc-1d90-4e98-b4fb-b9b0b30b2542

    Device Description

    SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWB Interventional Fluoroscopic X-Ray System
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

    GMDN Terms

    Code Name
    37649 Portable general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 08904269405519

    Premarket Submissions

    Submission Number Supplement Number
    K170946 000