AccessGUDID - DEVICE: Sonata® System Radiofrequency Generator (10817929020203)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® System Radiofrequency Generator
Version or Model: RFG2-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RFG2-110
Company Name: Gynesonics, Inc.

Primary DI Number: 10817929020203
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 generator

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?
58488	Ultrasound-guided intrauterine radio-frequency ablation system generator	A mains electricity (AC-powered) component of an ultrasound-guided intrauterine radio-frequency ablation system designed to generate a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat directly within soft-tissue cells for intrauterine ablation of uterine fibroids; the RF energy is delivered to the site of intervention via a dedicated handpiece and electrode. It also typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems. It is configured with dedicated application software and includes user interface/controls and inputs for other system components.	Obsolete	false

FDA Product Code

[?]

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

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
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: ea87d0f4-c4e0-482d-8421-bd912a80ca2b
Public Version Date: May 26, 2025
Public Version Number: 2
DI Record Publish Date: May 10, 2019