BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    CariFree Fluoride Varnish

    DI: 00856596006373 · Model: CTX2 · Dental Alliance Holdings LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CariFree Fluoride Varnish
    Primary DI
    00856596006373
    Version / Model
    CTX2
    Catalog Number
    Raspberry
    Company Name
    Dental Alliance Holdings LLC
    Labeler DUNS
    195544965
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-08
    Public Version
    2
    Public Version Date
    2022-02-11
    Public Version Status
    Update
    Public Device Record Key
    2a1ba1a0-488d-460d-bbad-d90c71d33ecb
    Distribution End Date
    2022-01-17

    Device Description

    A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LBH Varnish, Cavity

    GMDN Terms

    Code Name
    35698 Dental cavity varnish

    Identifiers

    Type ID
    Primary 00856596006373