AccessGUDID - DEVICE: Sonata® Sonography-Guided Transcervical Fibroid Ablation System (10817929020326)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System
Version or Model: SONATA2-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SONATA2-110
Company Name: Gynesonics, Inc.

Primary DI Number: 10817929020326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618493741 *Terms of Use

Device Description: Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit.

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?
58487	Ultrasound-guided intrauterine radio-frequency ablation system	A multicomponent assembly of devices that uses electrical energy in the radio-frequency (RF) band designed to develop heat directly within soft-tissue cells for transcervical and intrauterine ablation of uterine fibroids, and uses ultrasound to target the RF delivery. It consists of a radio-frequency generator, a software-controlled ultrasound system, an intrauterine ultrasound transducer, a monopolar electrosurgical handpiece/electrode, and a return electrode(s). It also typically includes associated cables, and a foot-switch.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -20 and 45 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c03567c-972a-4178-a380-6817191eabe2
Public Version Date: May 26, 2025
Public Version Number: 4
DI Record Publish Date: May 10, 2019