RADIFOCUS Obturator


Product Overview

RADIFOCUS Obturator
RADIFOCUS - XX502


Device Description

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile. Keep dry. Keep away from sunlight.

  • Device Sizes

  • Length: 25 Centimeter
  • Outer Diameter: 1.7 Millimeter
  • Those Clinically Relevant Size are relative to the compatible sheath.
    • Length: 25 Centimeter
    • Outer Diameter: 1.7 Millimeter
    • Those Clinically Relevant Size are relative to the compatible sheath.


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DYB

    Device Name: Introducer, Catheter

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    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: 870.1340

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 34987350774454

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350774453

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Shelfbox


    Device Id: 04987350774453

    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


    Device Id: 54987350774458

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 34987350774454

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos