BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BUTLER®

    DI: 10070942002025 · Model: 1219 · SUNSTAR AMERICAS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BUTLER®
    Primary DI
    10070942002025
    Version / Model
    1219
    Catalog Number
    P
    Company Name
    SUNSTAR AMERICAS, INC.
    Labeler DUNS
    025066358
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-30
    Public Version
    4
    Public Version Date
    2023-07-24
    Public Version Status
    Update
    Public Device Record Key
    a704d09b-5345-46fe-9c39-fc0ed0448c0f
    Distribution End Date
    2022-11-10

    Device Description

    MONSTERZ White liquid Fluoride Varnish, 5% w/w Sodium Fluoride

    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
    No
    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 10070942002025