BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DISCOVERY

    DI: 00840682124638 · Model: IGS 7 001 · GE MEDICAL SYSTEMS
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DISCOVERY
    Primary DI
    00840682124638
    Version / Model
    IGS 7 001
    Company Name
    GE MEDICAL SYSTEMS
    Labeler DUNS
    266062561
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-11
    Public Version
    5
    Public Version Date
    2023-10-20
    Public Version Status
    Update
    Public Device Record Key
    b0ff2325-cf7f-4127-bbab-a294e05eb1fb

    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
    OWB Interventional Fluoroscopic X-Ray System
    JAA System, X-Ray, Fluoroscopic, Image-Intensified
    IZI System, X-Ray, Angiographic

    GMDN Terms

    Code Name
    37623 Stationary angiographic x-ray system, digital

    Identifiers

    Type ID
    Primary 00840682124638

    Premarket Submissions

    Submission Number Supplement Number
    K181403 000