AVAtex Radiopaque Bone Cement


Product Overview

AVAtex Radiopaque Bone Cement
AVAtex - BCPM003


Device Description

A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Flash Point 50°F (10°C). Keep away from heat, sparks, open flame, and other sources of ignition. Store in a dark, dry place below 77°F (25°C) and protect from light.

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NDN

    Device Name: Cement, Bone, Vertebroplasty

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: Y

    Target Area: N/A

    Regulation Number: 888.3027

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 50885403002067

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403002069

    Package Quantity: 5

    Package Discontinue Date: 7/18/2017 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403002069

    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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