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UNC

The University of North Carolina Health System · Model UNC100EC · UDI-DI 10850045738065

FME
5
510(k) clearances
8
Adverse events (1 deaths)
1
Recalls
237
Facilities

Description

UNC Overhead SMS Gown, Thumbloops with Elastic Cuff, Open Back, Yellow, Universal

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.