BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orthodontic Relief Wax

    DI: D8199008900 · Model: 900890 · SPECIALTY APPLIANCES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Orthodontic Relief Wax
    Primary DI
    D8199008900
    Version / Model
    900890
    Company Name
    SPECIALTY APPLIANCES, LLC
    Labeler DUNS
    106645484
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-05
    Public Version
    1
    Public Version Date
    2024-03-13
    Public Version Status
    New
    Public Device Record Key
    206bb863-65ea-450c-a917-a59239cc33a7

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EGD Wax, Dental, Intraoral

    GMDN Terms

    Code Name
    34807 Wax dental impression material

    Identifiers

    Type ID
    Package D8199008909
    Primary D8199008900