BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Comfort Cover™

    DI: 00190707149048 · Model: 98165 · Ortho Organizers, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

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    Basic Information

    Brand Name
    Comfort Cover™
    Primary DI
    00190707149048
    Version / Model
    98165
    Company Name
    Ortho Organizers, Inc.
    Labeler DUNS
    062165188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2025-10-01
    Public Version
    3
    Public Version Date
    2025-12-30
    Public Version Status
    Update
    Public Device Record Key
    bd54de44-837e-45bd-a6f3-b08b3e6f555a

    Device Description

    Comfort Cover 5 sets per pack COMFORTCOVER

    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
    Yes
    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
    45251 Orthodontic appliance relief material

    Identifiers

    Type ID
    Unit of Use 10190707149045
    Primary 00190707149048