BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MARK3

    DI: D796114411 · Model: 1144 · CARGUS INTERNATIONAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    4

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    MARK3
    Primary DI
    D796114411
    Version / Model
    1144
    Company Name
    CARGUS INTERNATIONAL, INC
    Labeler DUNS
    096191093
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2018-11-12
    Public Version
    2
    Public Version Date
    2023-09-15
    Public Version Status
    Update
    Public Device Record Key
    b4f51375-86cd-4c9d-9bb6-a8e1d36b062a

    Device Description

    eXact VPS Impression Material Heavy Regular Set 50ml. Cartridges 4/bx. - 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
    Primary D796114411
    Unit of Use D7961144
    Package D79611442
    Package D79611443