Clinical Innovations, LLC

Manufacturing lot 1214-F-403 and 1214-V-424

Obstetrical and Gynecological Devices

2

No

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. || Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

Obstetrical and Gynecological Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.

Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO