BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Top Quality Manufacturing Bite Registration

    DI: TQ26126121201 · Model: 12612120 · TOP QUALITY MANUFACTURING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Top Quality Manufacturing Bite Registration
    Primary DI
    TQ26126121201
    Version / Model
    12612120
    Catalog Number
    12612120
    Company Name
    TOP QUALITY MANUFACTURING, INC.
    Labeler DUNS
    113630649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2021-01-05
    Public Version
    1
    Public Version Date
    2021-01-13
    Public Version Status
    New
    Public Device Record Key
    e6c37b8b-d638-4aa9-b70e-f843891e3c50

    Device Description

    Mousse-like, Fluffy Vinyl Polysiloxane Bite Registration Material Unflavored - Fast Set

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Unit of Use TQ26126121200
    Primary TQ26126121201