BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    G10x Slimline

    DI: 00860011903970 · Model: SS10E · Smartbox Assistive Technology Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    G10x Slimline
    Primary DI
    00860011903970
    Version / Model
    SS10E
    Company Name
    Smartbox Assistive Technology Inc.
    Labeler DUNS
    047962036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-14
    Public Version
    1
    Public Version Date
    2025-01-22
    Public Version Status
    New
    Public Device Record Key
    a49af37c-7295-4044-9c7b-d4c36f9e8796

    Device Description

    G10x Slimline Speech Generating Device

    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
    ILQ System, Communication, Powered

    GMDN Terms

    Code Name
    17187 Voice synthesizer/digitizer

    Identifiers

    Type ID
    Primary 00860011903970