BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Definium

    DI: 00195278913807 · Model: Pace Select ET · GE Hualun Medical Systems Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Definium
    Primary DI
    00195278913807
    Version / Model
    Pace Select ET
    Company Name
    GE Hualun Medical Systems Co., Ltd
    Labeler DUNS
    554408665
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-30
    Public Version
    2
    Public Version Date
    2025-03-14
    Public Version Status
    Update
    Public Device Record Key
    5d36ead6-cb89-4d7a-998b-b971142aa160

    Device Description

    Definium Pace Select ET System UDI

    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
    MQB Solid state x-ray imager (flat panel/digital imager)
    KPR System, x-ray, stationary

    GMDN Terms

    Code Name
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00195278913807

    Premarket Submissions

    Submission Number Supplement Number
    K242678 000