BONE FILLER DEVICE F06B DIRECT SIZE 2


Product Overview

BONE FILLER DEVICE F06B DIRECT SIZE 2
KYPHON Express Directional Bone Filler Device, Size 2 - F06B


Device Description

A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store in a cool, dry place

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KIH

    Device Name: Dispenser, Cement

    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: 888.4200

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 00763000025519

    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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