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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ziehm Vision FD

    DI: EZIEZIEHMVISIONFD1651 · Model: Vision FD · Ziehm Imaging GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ziehm Vision FD
    Primary DI
    EZIEZIEHMVISIONFD1651
    Version / Model
    Vision FD
    Company Name
    Ziehm Imaging GmbH
    Labeler DUNS
    322720541
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-12
    Public Version
    4
    Public Version Date
    2024-02-12
    Public Version Status
    Update
    Public Device Record Key
    48f986ce-0866-4ac4-8e7e-d9c9737c9a29

    Device Description

    Mobile C-arm

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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary EZIEZIEHMVISIONFD1651

    Premarket Submissions

    Submission Number Supplement Number
    K193230 000
    K231700 000
    K240020 000