BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    mmRNA appliance

    DI: 00810002220111 · Model: 3014680794 · JOHN'S DENTAL LABORATORY INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    mmRNA appliance
    Primary DI
    00810002220111
    Version / Model
    3014680794
    Company Name
    JOHN'S DENTAL LABORATORY INC
    Labeler DUNS
    016649253
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-04
    Public Version
    3
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    883827ef-fb0d-492d-8a88-0fc5c8548b72

    Device Description

    The mmRNA appliance is an intraoral device used for treating 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.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    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 00810002220111