BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precision

    DI: 00840682120982 · Model: 600FP · GE MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Precision
    Primary DI
    00840682120982
    Version / Model
    600FP
    Company Name
    GE MEDICAL SYSTEMS, INC.
    Labeler DUNS
    809785715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    57960062-13b3-42fb-a45c-c9e3d34bbedb

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAA System, x-ray, fluoroscopic, image-intensified

    GMDN Terms

    Code Name
    37679 Stationary general-purpose fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 00840682120982

    Premarket Submissions

    Submission Number Supplement Number
    K133553 000