AccessGUDID - DEVICE: Sonata® Radiofrequency Ablation Handpiece (10817929020371)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® Radiofrequency Ablation Handpiece
Version or Model: RFA-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RFA-002
Company Name: Gynesonics, Inc.

Primary DI Number: 10817929020371
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 handpiece/ electrode

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?
58493	Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode	A hand-held component of an ultrasound-guided intrauterine electrosurgical system consisting of both a handpiece and a monopolar electrode designed to provide an electrical connection between the output terminals of a dedicated electrosurgical generator and the target tissue (uterine fibroids). The handpiece is also used to deploy an introducer and an intrauterine ultrasound transducer. The electrode typically has an array of needle electrodes at the distal end and the device is connected to the generator proximally. The handpiece has two slider mechanisms to enable accurate advancement of the components controlled by an attached spacer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211535	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 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 595d6d08-a99c-4adf-a1e8-b83730fcd7ee
Public Version Date: May 26, 2025
Public Version Number: 3
DI Record Publish Date: July 07, 2021