BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TrakStar Patient Data Management System Software

    DI: 00850005944553 · Model: Version 7.8 (Cloud) · NEURONETICS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TrakStar Patient Data Management System Software
    Primary DI
    00850005944553
    Version / Model
    Version 7.8 (Cloud)
    Catalog Number
    83-00090-000
    Company Name
    NEURONETICS, INC.
    Labeler DUNS
    134960348
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-03
    Public Version
    1
    Public Version Date
    2024-01-11
    Public Version Status
    New
    Public Device Record Key
    3618ec36-8a4a-4cdb-936d-5753ad494072

    Device Description

    Cloud version of TrakStar Patient Data Management System Software

    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
    No
    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
    QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
    OBP Transcranial Magnetic Stimulator

    GMDN Terms

    Code Name
    61124 Magnetic neural stimulation system

    Identifiers

    Type ID
    Primary 00850005944553

    Customer Contacts

    Phone
    877-600-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K233621 000