BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00840682141307 · Model: IGS WF SP · GE MEDICAL SYSTEMS
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00840682141307
    Version / Model
    IGS WF SP
    Company Name
    GE MEDICAL SYSTEMS
    Labeler DUNS
    266062561
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-29
    Public Version
    2
    Public Version Date
    2020-09-14
    Public Version Status
    Update
    Public Device Record Key
    1a4306c0-c8a2-4adf-8458-df4edd63cfe8

    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
    Yes
    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
    IZI System, x-ray, angiographic
    JAA System, x-ray, fluoroscopic, image-intensified

    GMDN Terms

    Code Name
    36336 Foot-switch, electrical

    Identifiers

    Type ID
    Primary 00840682141307

    Premarket Submissions

    Submission Number Supplement Number
    K181403 000