BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Vivos DNA-Lower

    DI: 00810002220159 · Model: 3014680794 · JOHN'S DENTAL LABORATORY INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vivos DNA-Lower
    Primary DI
    00810002220159
    Version / Model
    3014680794
    Company Name
    JOHN'S DENTAL LABORATORY INC
    Labeler DUNS
    016649253
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-13
    Public Version
    3
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    a54ff347-f362-4e77-888d-78171beb6dc9
    Distribution End Date
    2023-03-01

    Device Description

    Lower mouth guard, migraine/tension headache, Jaw repositioning device

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCO Mouthguard, Migraine/Tension Headache

    GMDN Terms

    Code Name
    58288 Dental appliance fabrication material, thermoplastic

    Identifiers

    Type ID
    Primary 00810002220159