BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MagPro

    DI: 05713484020437 · Model: Cool-B65 CO · Tonica Elektronik A/S
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MagPro
    Primary DI
    05713484020437
    Version / Model
    Cool-B65 CO
    Catalog Number
    9016E0151
    Company Name
    Tonica Elektronik A/S
    Labeler DUNS
    566622973
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-29
    Public Version
    2
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    efaf7985-1e0b-4032-9135-607b8a345845

    Device Description

    Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an accessory to the predicate MagVenture TMS Therapy System (K150641, K171481 and K171967).

    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 Unsafe
    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
    GWF Stimulator, Electrical, Evoked Response

    GMDN Terms

    Code Name
    61124 Magnetic neural stimulation system

    Identifiers

    Type ID
    Primary 05713484020437

    Customer Contacts

    Phone
    888 624 7764
    Email
    [email protected]