AccessGUDID - DEVICE: N/A (10888551045087)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: R10439011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R10439011
Company Name: STERILMED, INC.

Primary DI Number: 10888551045087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
61811	Intracardiac ultrasound imaging catheter, steerable, reprocessed	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 an ultrasound system for image transmission/display. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWQ	Reprocessed intravascular ultrasound catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161700	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99e07352-060e-47e6-be10-a156208c222a
Public Version Date: August 14, 2019
Public Version Number: 5
DI Record Publish Date: February 15, 2017