RADIFOCUS GLIDECATH


Product Overview

RADIFOCUS GLIDECATH
GLIDECATH - CG513


Device Description

A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

  • Device Sizes

  • Pressure: 6895 KiloPascal
  • Outer Diameter: 1.70 Millimeter
  • Max Guide Wire O.D. : .038" (0.97mm)
  • Hydrophilic Coating Length : 40cm
  • Length: 100 Centimeter
    • Pressure: 6895 KiloPascal
    • Outer Diameter: 1.70 Millimeter
    • Max Guide Wire O.D. : .038" (0.97mm)
    • Hydrophilic Coating Length : 40cm
    • Length: 100 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQO

    Device Name: Catheter, Intravascular, Diagnostic

    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: 870.1200

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 54987350772577

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 34987350772573

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 34987350772573

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350772572

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Shelfbox


    Device Id: 04987350772572

    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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