Sonata® Intrauterine Ultrasound Probe

Basic Information

• Brand Name: Sonata® Intrauterine Ultrasound Probe
• Primary DI: 10817929020241
• Version / Model: IUSP-002S
• Catalog Number: IUSP-002S
• 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: 3
• Public Version Date: 2020-04-16
• Public Version Status: Update
• Public Device Record Key: aab28921-ca11-4a18-9098-96c07adeff55

Device Description

Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile

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: 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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	884.4160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64389	Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable	A component of an ultrasound-guided intrauterine radio-frequency (RF) ablation system designed to convert electric voltages into an ultrasound beam to produce intrauterine ultrasound images used to monitor/guide electrosurgical procedures. It is typically used as part of a dedicated handpiece and is inserted transcervically into the uterus where it is intended to be manually manoeuvred to steer/focus the ultrasound beam for visualization of uterine pathology (e.g., fibroids). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10817929020098	GS1
Primary	10817929020241	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 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity