BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MARK3

    DI: D79690011 · Model: 9001 · CARGUS INTERNATIONAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    MARK3
    Primary DI
    D79690011
    Version / Model
    9001
    Company Name
    CARGUS INTERNATIONAL, INC
    Labeler DUNS
    096191093
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2025-02-28
    Public Version
    1
    Public Version Date
    2025-03-10
    Public Version Status
    New
    Public Device Record Key
    764d5dc6-d9f5-4b29-b6c8-8d34a18b85c2

    Device Description

    Alginate Alternative Regular Set 50ml. Cartridges 4/pk. - MARK3®

    Device Characteristics

    Single Use
    No
    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
    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
    ELW Material, Impression

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Unit of Use D7969001
    Primary D79690011