Pearl 5.0 Handpiece Delivery System


Product Overview

Pearl 5.0 Handpiece Delivery System
CardioGenesis - HP-PRL5


Device Description

A sterile, flexible, probe-like device intended to be connected to a cardiac laser system for the delivery of laser energy directly onto the heart during transmyocardial revascularization surgery (open surgical approach). It includes fibreoptic materials whereby a distal laser fibre of a specific width is intended to penetrate myocardium to create channels for the promotion of angiogenesis; it may include distal needles/tubing to allow injection of agents into the myocardium. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • clean, dry environment under conditions that protect against extremes in temperature and humidity

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MNO

    Device Name: System, Laser, Transmyocardial Revascularization

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00877234000119

    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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