Product Overview

SOUNDSTAR - 10439072


Device Description

A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Do not use if package is damaged
  • Special Storage Condition, Specify
    • Do not use if package is opened
  • Special Storage Condition, Specify
    • Keep Dry
  • Special Storage Condition, Specify
    • Keep out of direct sunlight
  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OBJ

    Device Name: Catheter, Ultrasound, Intravascular

    Device Class: 2

    Physical State: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

    Definition: For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Cardiovascular anatomy and physiology.

    Regulation Number: 870.1200

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 10846835008845

    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


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