BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ActivaTek Ionto4 Butterfly

    DI: 10768627016312 · Model: NC89378 · NORTH COAST MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ActivaTek Ionto4 Butterfly
    Primary DI
    10768627016312
    Version / Model
    NC89378
    Catalog Number
    4511
    Company Name
    NORTH COAST MEDICAL, INC.
    Labeler DUNS
    060121928
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-02
    Public Version
    1
    Public Version Date
    2025-04-10
    Public Version Status
    New
    Public Device Record Key
    b895cd61-b3bb-457f-bd98-0bf3a1db2abd

    Device Description

    ActivaTek Ionto4 Butterfly (12)

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EGJ Device, Iontophoresis, Other Uses

    GMDN Terms

    Code Name
    66709 Multi-modality electrotherapy system

    Identifiers

    Type ID
    Package 20768627016319
    Primary 10768627016312

    Customer Contacts

    Phone
    4087765000
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 150 Degrees Fahrenheit