BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OCD MT Cap

    DI: 00850005944683 · Model: 85-00397-000 · NEURONETICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OCD MT Cap
    Primary DI
    00850005944683
    Version / Model
    85-00397-000
    Company Name
    NEURONETICS, INC.
    Labeler DUNS
    134960348
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-16
    Public Version
    1
    Public Version Date
    2023-08-24
    Public Version Status
    New
    Public Device Record Key
    b3b08341-d7c4-4b74-a142-b062ba4cf436

    Device Description

    The OCD MT Cap is used to aid in the OCD motor threshold (MT) determination process.

    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
    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
    QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

    GMDN Terms

    Code Name
    61124 Magnetic neural stimulation system

    Identifiers

    Type ID
    Package 10850005944680
    Primary 00850005944683

    Customer Contacts

    Phone
    877-600-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K231350 000