BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ISSA™ mini

    DI: 07350071074947 · Model: MANGO TANGO · Foreo AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ISSA™ mini
    Primary DI
    07350071074947
    Version / Model
    MANGO TANGO
    Company Name
    Foreo AB
    Labeler DUNS
    352394143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-26
    Public Version
    1
    Public Version Date
    2022-06-03
    Public Version Status
    New
    Public Device Record Key
    9371d386-7522-4fe7-bdc8-937eb43cc4cb

    Device Description

    ISSA™ mini is a powered toothbrush that helps parents to monitor that their children are brushing their teeth twice a day. Featuring parental controls, the sad face ('Glum') will appear if teeth haven't been brushed in over 12 hours. The happy face ('Glee') will appear when teeth have been brushed for 2 minutes. With 2 speed settings, you can ensure your child is cleaning their teeth effectively. The ISSA™ mini is suitable for children ages 5+.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JEQ Toothbrush, Powered

    GMDN Terms

    Code Name
    43090 Basic electric toothbrush

    Identifiers

    Type ID
    Primary 07350071074947