AccessGUDID - DEVICE: Sonata® System Software (10817929020357)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® System Software
Version or Model: SW-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SW-001
Company Name: Gynesonics, Inc.

Primary DI Number: 10817929020357
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 618493741 *Terms of Use

Device Description: Ultrasound-guided radio-frequency ablation system software

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:	No
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?
64353	Ultrasound-guided radio-frequency ablation system software	A software program intended to be used by a healthcare professional for control of, and data extraction from, an ultrasound-guided radio-frequency ablation system. The software is intended to collect and display ultrasound data in real-time while controlling radio-frequency ablation functions, and may have additional workflow-assistive feature capabilities (e.g., alarms, prompts).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
ITX	Transducer, Ultrasonic, Diagnostic
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173703	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: bd557c4f-a8c2-4bf5-8ef1-2b60d3ca7df1
Public Version Date: May 26, 2025
Public Version Number: 3
DI Record Publish Date: February 21, 2020