- Physicians Office Resource

SOUNDSTAR CRYSTAL Ultrasound Catheter
SOUNDSTAR CRYSTAL Ultrasound Catheter - 11510826

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 opened

Special Storage Condition, Specify

Keep away from sunlight

Special Storage Condition, Specify

Keep dry

Special Storage Condition, Specify

Do not use if package is damage

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
0.00

Storage Environment Temperature - Degrees Celsius

25.00
5.00

Storage Environment Temperature - Degrees Fahrenheit

77.00
41.00

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: 10846835022780

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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