BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ISSA™ play

    DI: 07350092135191 · Model: COOL BLACK · Foreo AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ISSA™ play
    Primary DI
    07350092135191
    Version / Model
    COOL BLACK
    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
    204af939-d5c0-4da2-90be-950bcee9ca4a

    Device Description

    ISSA™ play is a powered toothbrush that is specifically engineered to utilize soft silicone bristles for the gum area, the ISSA™ play also integrates PBT polymer bristles with hygienic properties superior to standard nylon bristles. This dynamic cross-design is designed to target plaque buildup for a clean that’s sure to put a smile on your face.

    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 07350092135191