BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fluorilaq Mint (10mL) Tube

    DI: 00310866002668 · Model: 10406 · PASCAL COMPANY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Fluorilaq Mint (10mL) Tube
    Primary DI
    00310866002668
    Version / Model
    10406
    Company Name
    PASCAL COMPANY, INC.
    Labeler DUNS
    009260217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-28
    Public Version
    1
    Public Version Date
    2024-04-05
    Public Version Status
    New
    Public Device Record Key
    cefed392-144c-47bb-9f64-d1b24f4ffde8

    Device Description

    5% Fluoride Varnish with Xylitol. Ideal for cavity varnish.

    Device Characteristics

    Single Use
    No
    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
    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 00310866002668

    Customer Contacts

    Phone
    4258274694
    Email
    [email protected]