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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bosworth Pit & Fissure

    DI: H6680921561 · Model: 092156 · Harry J Bosworth Company
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    Bosworth Pit & Fissure
    Primary DI
    H6680921561
    Version / Model
    092156
    Catalog Number
    092156
    Company Name
    Harry J Bosworth Company
    Labeler DUNS
    014769301
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    0d250084-fa80-42d3-a7af-9442e3fe9a8b

    Device Description

    Pit & Fissure LC Sealant w Fluoride

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    EBC SEALANT, PIT AND FISSURE, AND CONDITIONER

    GMDN Terms

    Code Name
    31780 Dental pit/fissure sealant

    Identifiers

    Type ID
    Primary H6680921561
    Unit of Use H6680921560

    Customer Contacts

    Phone
    +1(800)333-3131 ext. 8455
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Total Volume 1.2 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    32 – 86 Degrees Fahrenheit
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from moisture
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep out of direct sunlight