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Sonata® Sonography-Guided Transcervical Fibroid Ablation System

FDA UDI

Class II (US FDA UDI)

by Gynesonics, Inc.

Identity

Trade Name
Sonata® Sonography-Guided Transcervical Fibroid Ablation System FDA UDI
Generic Name
Ultrasound-guided intrauterine radio-frequency ablation system FDA UDI
Device Name
Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit. FDA UDI
Model / Reference
SONATA2-110 FDA UDI
Description
Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit. FDA UDI

Identifiers

Catalog Number
SONATA2-110 FDA UDI
Primary DI / UDI-DI
10817929020326 FDA UDI
FDA Product Code
ITX FDA UDI
KNF FDA UDI
IYO FDA UDI
GMDN Term
Ultrasound-guided intrauterine radio-frequency ablation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
884.4160 FDA UDI
892.1560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound-guided intrauterine radio-frequency ablation system

Sonata® Sonography-Guided Transcervical Fibroid Ablation System by Gynesonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gynesonics, Inc.

Sources (1)

  • FDA UDI 1c03567c-972a-4178-a380-6817191eabe2 36 fields · synced May 30, 2026