BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tracking Array for Brainpath

    DI: 00670082000030 · Model: SYN-0015 · Synaptive Medical Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tracking Array for Brainpath
    Primary DI
    00670082000030
    Version / Model
    SYN-0015
    Company Name
    Synaptive Medical Inc
    Labeler DUNS
    203061833
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-12-26
    Public Version Status
    Update
    Public Device Record Key
    962e7d8a-14f0-45a8-99c1-b48d6b67013a

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological Stereotaxic Instrument

    GMDN Terms

    Code Name
    32568 Neurological stereotactic surgery system

    Identifiers

    Type ID
    Primary 00670082000030
    Package 10670082000037

    Premarket Submissions

    Submission Number Supplement Number
    K153281 000
    K183325 000