Sonata® SMART Tablet

Basic Information

• Brand Name: Sonata® SMART Tablet
• Primary DI: 10817929020197
• Version / Model: USCON-2200
• Catalog Number: USCON-2200
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-10
• Public Version: 2
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 0050efa6-cff2-4269-93ea-196cafa3d2e2

Device Description

Ultrasound -guided intrauterine electrosurgical system ultrasound control unit

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	884.4160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58489	Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit	A mains electricity (AC-powered) component of an ultrasound-guided intrauterine electrosurgical system designed to provide ultrasound imaging via a transvaginal and intrauterine ultrasound imaging transducer. The imaging is used to guide the radio-frequency (RF) ablation treatment. It typically consists of a laptop computer with an embedded ultrasound engine and installed graphical user interface software, which provides standard ultrasound controls and procedure-specific guidance for fibroid ablation planning, targeting, and procedural workflow.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020197	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173703	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity