BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NeuSight PET/CT Scanner System

    DI: 06970167440053 · Model: NeuSight PET/CT 64 · Neusoft Medical Systems Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeuSight PET/CT Scanner System
    Primary DI
    06970167440053
    Version / Model
    NeuSight PET/CT 64
    Company Name
    Neusoft Medical Systems Co., Ltd.
    Labeler DUNS
    724421537
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    4
    Public Version Date
    2023-06-29
    Public Version Status
    Update
    Public Device Record Key
    3d42cf68-e119-4e56-be6a-36dc7594c6ad
    Distribution End Date
    2018-06-14

    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
    JAK System, X-Ray, Tomography, Computed
    KPS System, Tomography, Computed, Emission

    GMDN Terms

    Code Name
    45143 PET/CT system

    Identifiers

    Type ID
    Primary 06970167440053