BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    eXciteOSA

    DI: 05060627480024 · Model: 802300000 · SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    eXciteOSA
    Primary DI
    05060627480024
    Version / Model
    802300000
    Company Name
    SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
    Labeler DUNS
    220701035
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-14
    Public Version
    1
    Public Version Date
    2024-08-22
    Public Version Status
    New
    Public Device Record Key
    927fca2d-b78c-4751-99e9-c1c2b9a9780f

    Device Description

    eXciteOSA control unit. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

    GMDN Terms

    Code Name
    63489 Sleep-disordered breathing tongue electrical stimulator

    Identifiers

    Type ID
    Primary 05060627480024