BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Audit MicroControls Control FD Traumatic Brain Injury (TBI)

    DI: B085K083M80 · Model: K083M-8 · AALTO SCIENTIFIC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Audit MicroControls Control FD Traumatic Brain Injury (TBI)
    Primary DI
    B085K083M80
    Version / Model
    K083M-8
    Company Name
    AALTO SCIENTIFIC
    Labeler DUNS
    077974989
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-25
    Public Version
    1
    Public Version Date
    2026-04-02
    Public Version Status
    New
    Public Device Record Key
    690f6342-31bd-41dc-be6d-d653f2006cac

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    65356 Multiple traumatic brain injury marker IVD, control

    Identifiers

    Type ID
    Primary B085K083M80