FDA 483 - Dib Tranav Medical, LLC

During an inspection, Dib Ultranav Medical LLC, a device manufacturer, was cited for a compliance issue related to device identification. The firm failed to electronically submit unique device identification information for its Dib UltraNav Transseptal Catheter System and Introducer Catheter to FDA's Global Unique Device Identification Database (GUDID). This indicates a lapse in regulatory reporting for medical devices.