BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NeuroStar TMS Therapy System

    DI: 00869378000148 · Model: Multi-Coil Option Upgrade · NEURONETICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NeuroStar TMS Therapy System
    Primary DI
    00869378000148
    Version / Model
    Multi-Coil Option Upgrade
    Catalog Number
    81-30000-000
    Company Name
    NEURONETICS, INC.
    Labeler DUNS
    134960348
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    6
    Public Version Date
    2023-01-20
    Public Version Status
    Update
    Public Device Record Key
    9bb1d1c3-78a6-4352-b66e-ff9cf07fdabc
    Distribution End Date
    2023-01-19

    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
    MR Safe
    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
    OBP Transcranial Magnetic Stimulator

    GMDN Terms

    Code Name
    61124 Magnetic neural stimulation system

    Identifiers

    Type ID
    Primary 00869378000148

    Customer Contacts

    Phone
    877-600-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN070003 000