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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ziehm Vision RFD 3D

    DI: EZIEZIEHMVISIONRFD3D1 · Model: Vision RFD 3D · Ziehm Imaging GmbH
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ziehm Vision RFD 3D
    Primary DI
    EZIEZIEHMVISIONRFD3D1
    Version / Model
    Vision RFD 3D
    Company Name
    Ziehm Imaging GmbH
    Labeler DUNS
    322720541
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    7
    Public Version Date
    2024-02-12
    Public Version Status
    Update
    Public Device Record Key
    92b664b9-9f70-41a6-bea9-fd02b53110ae

    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
    JAK System, X-Ray, Tomography, Computed
    JAA System, X-Ray, Fluoroscopic, Image-Intensified
    OWB Interventional Fluoroscopic X-Ray System

    GMDN Terms

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

    Identifiers

    Type ID
    Primary EZIEZIEHMVISIONRFD3D1

    Premarket Submissions

    Submission Number Supplement Number
    K142740 000
    K202360 000
    K231701 000