BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Triton System (Sponge)

    DI: 00859506006050 · Model: GAUS-01 · GAUSS SURGICAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Triton System (Sponge)
    Primary DI
    00859506006050
    Version / Model
    GAUS-01
    Company Name
    GAUSS SURGICAL, INC
    Labeler DUNS
    968757448
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-05
    Public Version
    3
    Public Version Date
    2018-05-15
    Public Version Status
    Update
    Public Device Record Key
    9fd5a683-d9c4-4f31-97ec-2db54e1dac44
    Distribution End Date
    2018-05-06

    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
    PBZ Image Processing Device For Estimation Of External Blood Loss

    GMDN Terms

    Code Name
    61696 Blood loss estimation application software

    Identifiers

    Type ID
    Primary 00859506006050