# FDA 483 - Sustain Medical, LLC - March 21, 2024

Source: https://www.keypedia.com/records/483/sustain-medical-llc/1e182279-2d32-498f-8dd6-8f53a642fd44

> FDA 483 for Sustain Medical, LLC on March 21, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sustain Medical, LLC
- Inspection Date: 2024-03-21
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Sustain Medical, LLC in Concord, MA, from March 11-21, 2024, revealed one significant observation. The firm failed to provide required information to the Global Unique Device Identification Database (GUDID) for its Tru-Flo Ortho Surgical Filter System. This indicates a lapse in compliance with medical device identification regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/sustain-medical-llc/dbffeceb-4731-4d18-b815-bc6520faf8c8

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144