483
Sustain Medical, LLCSustain Medical, LLC – FDA 483, Mar 21, 2024
Record Details
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.
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ID · 1e182279-2d32-498f-8dd6-8f53a642fd44
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