RADIFOCUS GLIDEWIRE


Product Overview

RADIFOCUS GLIDEWIRE
GLIDEWIRE - GR3519


Device Description

A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.


Environmental Conditions

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

  • Device Sizes

  • Flexible Tip Length: 1cm
  • Length: 180 Centimeter
  • Outer Diameter: 0.89 Millimeter
    • Flexible Tip Length: 1cm
    • Length: 180 Centimeter
    • Outer Diameter: 0.89 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQX

    Device Name: Wire, Guide, 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: 870.1330

    Third Party Flag: Y

    Medical Specialty: CV


    Code: GCJ

    Device Name: Laparoscope, General & Plastic Surgery

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: SU

    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: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 34987350778490

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350778499

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Shelfbox


    Device Id: 04987350778499

    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: 54987350778494

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 34987350778490

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


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