BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Silkn

    DI: 06975782191434 · Model: X20B · Guangdong Roaman Intelligent Technology Co Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Silkn
    Primary DI
    06975782191434
    Version / Model
    X20B
    Company Name
    Guangdong Roaman Intelligent Technology Co Ltd
    Labeler DUNS
    560456173
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-24
    Public Version
    1
    Public Version Date
    2025-06-02
    Public Version Status
    New
    Public Device Record Key
    512321d9-c5f2-4bf0-afa7-c85ce1a26740

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    63584 Water jet flosser/sonic electric toothbrush

    Identifiers

    Type ID
    Primary 06975782191434