BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    2Mix Gun

    DI: 08031497002057 · Model: ASA0310 · TECRES SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    2Mix Gun
    Primary DI
    08031497002057
    Version / Model
    ASA0310
    Company Name
    TECRES SPA
    Labeler DUNS
    435428396
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-12
    Public Version
    1
    Public Version Date
    2024-02-20
    Public Version Status
    New
    Public Device Record Key
    3500c1d1-6d1b-434f-8e0c-3f147f52984a

    Device Description

    2Mix Gun is designed to aid the extrusion of bone cement from 2Mix.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KIH Dispenser, Cement

    GMDN Terms

    Code Name
    47703 Orthopaedic cement/bone filler dispensing gun

    Identifiers

    Type ID
    Primary 08031497002057