BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MARK3

    DI: D79680901 · Model: 8090 · CARGUS INTERNATIONAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    400

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    Basic Information

    Brand Name
    MARK3
    Primary DI
    D79680901
    Version / Model
    8090
    Catalog Number
    8090
    Company Name
    CARGUS INTERNATIONAL, INC
    Labeler DUNS
    096191093
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    400
    Record Status
    Published
    Publish Date
    2022-06-21
    Public Version
    1
    Public Version Date
    2022-06-29
    Public Version Status
    New
    Public Device Record Key
    63ca494e-6e07-499c-94e1-4ca4831d0d4b

    Device Description

    Disposable Micro Applicators Regular Assorted Colors (Blue,Green,Orange,Purple) 400/bx. - MARK3®

    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
    Yes
    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
    EJB Handle, Instrument, Dental

    GMDN Terms

    Code Name
    35697 Dental material application tool, single-use

    Identifiers

    Type ID
    Unit of Use D79680902
    Primary D79680901