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Product Overview

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IVAS - 0306230000


Device Description

A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Needle Gauge: 13.0 Gauge
    • Needle Gauge: 13.0 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OAR

    Device Name: Injector, Vertebroplasty (Does Not Contain Cement)

    Device Class: 1

    Physical State: plastic syringe type device -- some embodiments may include levers or screws to increase injection force or control

    Definition: Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    Submission Type ID: 4

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses mechanical force to inject bone cement into vertebra

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: vertebra

    Regulation Number: 888.4200

    Third Party Flag: N

    Medical Specialty: OR


    Device Identifiers

    Device Id: 37613327374453

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327374452

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 07613327374452

    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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