# FDA 483 - Dib Tranav Medical, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/dib-tranav-medical-llc/bd5310dc-da47-4af8-8a23-b67179f4be68

> FDA 483 for Dib Tranav Medical, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dib Tranav Medical, LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [Amber Smith, R.S. Sanitarian II](https://www.keypedia.com/people/amber-smith-rs-sanitarian-ii/e51c4c15-a95d-406f-ab3c-17a8b966bee3)

Company: https://www.keypedia.com/companies/dib-tranav-medical-llc/ac45aea2-c8c2-4bf3-9cf2-2d3a9c64731b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab