Sonata System Software

Basic Information

• Brand Name: Sonata System Software
• Primary DI: 10817929020340
• Version / Model: SW-002
• Catalog Number: SW-002
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 1
• Public Version Date: 2020-10-15
• Public Version Status: New
• Public Device Record Key: dd340bef-aeaa-43c4-b60f-076bd1393ac6

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020340	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193516	000