HEADLINER Hydrophilic Coated Guidewire


Product Overview

HEADLINER Hydrophilic Coated Guidewire
HEADLINER - GM1221


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. LIMIT STACK TO10.

  • Device Sizes

  • Outer Diameter: 0.30 Millimeter
  • 45 degree ANGLED
  • Length: 200 Centimeter
    • Outer Diameter: 0.30 Millimeter
    • 45 degree ANGLED
    • Length: 200 Centimeter


    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


    Device Identifiers

    Device Id: 54987350774274

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350774279

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04987350774279

    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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