BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00195278124609 · Model: SIGNA Voyager · GE Medical Systems (Tianjin) Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00195278124609
    Version / Model
    SIGNA Voyager
    Company Name
    GE Medical Systems (Tianjin) Co., Ltd.
    Labeler DUNS
    421356265
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-02
    Public Version
    2
    Public Version Date
    2022-10-20
    Public Version Status
    Update
    Public Device Record Key
    d4eceb58-c2cd-4d9f-95d9-2b2f876ea174

    Device Description

    Kizuna System Medical Device Assembly-MDR

    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
    LNH System, nuclear magnetic resonance imaging
    MOS Coil, magnetic resonance, specialty

    GMDN Terms

    Code Name
    37654 Full-body MRI system, superconducting magnet

    Identifiers

    Type ID
    Primary 00195278124609