Sonata® Radiofrequency Ablation Handpiece

Basic Information

• Brand Name: Sonata® Radiofrequency Ablation Handpiece
• Primary DI: 10817929020371
• Version / Model: RFA-002
• Catalog Number: RFA-002
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-07
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: 595d6d08-a99c-4adf-a1e8-b83730fcd7ee

Device Description

Ultrasound-guided intrauterine electrosurgical handpiece/ electrode

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	884.4160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211535	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius