BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vivos mmRNA

    DI: 00810106971452 · Model: 5.016 · Aurum Group Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vivos mmRNA
    Primary DI
    00810106971452
    Version / Model
    5.016
    Company Name
    Aurum Group Ltd
    Labeler DUNS
    243286441
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-21
    Public Version
    1
    Public Version Date
    2023-09-29
    Public Version Status
    New
    Public Device Record Key
    78e4a7d3-abdf-4dbf-b730-9d1a1df172e7

    Device Description

    The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    LRK Device, Anti-Snoring
    LQZ Device, Jaw Repositioning

    GMDN Terms

    Code Name
    47526 Mandible-repositioning sleep-disordered breathing orthosis

    Identifiers

    Type ID
    Primary 00810106971452