Australia TGA ARTG recordThe Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical
Australia TGA ARTG Registered Device · Avention Global Pty Ltd · Gynesonics Inc · Class I · Started September 07, 2022
Good Name: Avention Global Pty Ltd - The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- September 07, 2022
- Effective Date
- September 07, 2022
- Name
- Gynesonics Inc
- Country
- United States of America
- Address
- 600 Chesapeake Drive, Redwood City, CA, 94063
Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Consists of a manual inflation bulb and tubing with connector for attachment to the Sonata® IUUS Probe Connector Cover. Intended to identify the presence of leaks in the Sonata® IUUS Probe by immersing in water and visually observing for bubbles. The leak tester is intended to enhance visual inspection to verify that the structural integrity of the IUUS Probe remains intact and is therefore able to be reprocessed for next use
Access comprehensive regulatory information for The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Avention Global Pty Ltd, manufactured by Gynesonics Inc in United States of America. The device registration started on September 07, 2022.
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