BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Repair-It

    DI: 00010705400913 · Model: 1 · MAJESTIC DRUG CO. INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Repair-It
    Primary DI
    00010705400913
    Version / Model
    1
    Company Name
    MAJESTIC DRUG CO. INC.
    Labeler DUNS
    001496777
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-27
    Public Version
    3
    Public Version Date
    2020-11-06
    Public Version Status
    Update
    Public Device Record Key
    f16881eb-9b42-40d3-bfbc-298ca91a4738

    Device Description

    Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    EBO Over The Counter Denture Repair Kit

    GMDN Terms

    Code Name
    31787 Denture repair kit, home-use

    Identifiers

    Type ID
    Package 20010705400917
    Package 70010705400912
    Primary 00010705400913
    Package 30010705400914

    Customer Contacts

    Phone
    800-238-0220
    Email
    [email protected]