Sonata® IUUS Probe Sterile Shipper Kit

FDA UDI

GYNESONICS, INC.·10817929020135·Sterilization packaging, single use

Sonata® IUUS Probe Leak Tester

FDA UDI

GYNESONICS, INC.·30817929020450·Invasive medical device leak tester, mechanical.

Sonata® Dispersive Electrode

FDA UDI

GYNESONICS, INC.·10817929020364·Electrosurgical return electrode, single-use

Sonata® Case Kit

FDA UDI

GYNESONICS, INC.·10817929020005·Convenience Kit containing one model RFA-001 st...

Sonata® Intrauterine Ultrasound Probe

FDA UDI

GYNESONICS, INC.·10817929020241·Ultrasound-guided intrauterine electrosurgical ...

Sonata® System Radiofrequency Generator

FDA UDI

GYNESONICS, INC.·10817929020203·Ultrasound-guided intrauterine electrosurgical ...

Sonata® Procedure Kit

FDA UDI

GYNESONICS, INC.·10817929020166·Convenience Kit containing one model RFA-002 st...

Sonata Sonography-Guided Transcervical Fibroid Ablation System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata Transcervical Fibroid Ablation System 2.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata Transcervical Fibroid Ablation System 2.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYNESONICS EC6 TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

Sonata Transcervical Fibroid Ablation System 2.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata Transcervical Fibroid Ablation System 2.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sonata® Transcervical Fibroid Ablation System

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Gynesonics, Inc.·1 device

Gynesonics, Inc.

System producer

🇺🇸 United States

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

MedEnvoy Global BV

Importer

🇳🇱 Netherlands·234 Manufacturers