BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    L8 Slimline

    DI: B925TS08EL80 · Model: TS08E-L8 · Smartbox Assistive Technology Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    L8 Slimline
    Primary DI
    B925TS08EL80
    Version / Model
    TS08E-L8
    Company Name
    Smartbox Assistive Technology Inc.
    Labeler DUNS
    047962036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-26
    Public Version
    1
    Public Version Date
    2023-10-04
    Public Version Status
    New
    Public Device Record Key
    09f5719a-543d-4514-935a-44a589999e1e

    Device Description

    L8 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 B925TS08EL80