BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXTRON 5

    DI: 08800018420805 · Model: EXTRON 5 · DRTECH Corporation
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXTRON 5
    Primary DI
    08800018420805
    Version / Model
    EXTRON 5
    Company Name
    DRTECH Corporation
    Labeler DUNS
    689842626
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-24
    Public Version
    1
    Public Version Date
    2023-09-01
    Public Version Status
    New
    Public Device Record Key
    16922c0f-5352-482a-a75b-d7fc3a6e6ccc

    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37646 Mobile general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 08800018420805

    Premarket Submissions

    Submission Number Supplement Number
    K230871 000