BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ELITONE URGE

    DI: 00851096008100 · Model: EK-1016 · ELIDAH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ELITONE URGE
    Primary DI
    00851096008100
    Version / Model
    EK-1016
    Company Name
    ELIDAH, INC.
    Labeler DUNS
    079300140
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-13
    Public Version
    1
    Public Version Date
    2023-04-21
    Public Version Status
    New
    Public Device Record Key
    1c43537a-61cd-4a18-90d6-ee97b1c58bdf

    Device Description

    Muscle stimulator for the treatment of urge urinary incontinence.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    QAJ Cutaneous Electrode Stimulator For Urinary Incontinence

    GMDN Terms

    Code Name
    65016 Transcutaneous incontinence-control electrical stimulator

    Identifiers

    Type ID
    Primary 00851096008100