AccessGUDID - DEVICE: SOUNDSTAR CRYSTAL Ultrasound Catheter (10846835022780)

GUDID

Device Identifier (DI) Information

Brand Name: SOUNDSTAR CRYSTAL Ultrasound Catheter
Version or Model: 11510826
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11510826
Company Name: Biosense Webster Inc

Primary DI Number: 10846835022780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: SOUNDSTAR CRYSTAL Ultrasound Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42584	Intracardiac ultrasound imaging catheter, steerable, single-use	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBJ	Catheter, ultrasound, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240050	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7cab52bc-75a5-40d6-92ab-ccea0725539f
Public Version Date: March 07, 2025
Public Version Number: 2
DI Record Publish Date: June 26, 2024