Bowl and Cement Cartridge with Breakaway Femoral Nozzle


Product Overview

Bowl and Cement Cartridge with Breakaway Femoral Nozzle
ACM - 0306563000


Device Description

A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Weight: 180.0 Gram
    • Weight: 180.0 Gram


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JDZ

    Device Name: Mixer, Cement, For Clinical Use

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 888.4210

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 34546540055409

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04546540055408

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 04546540055408

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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