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Copioumed
COPIOUMED INTERNATIONAL INC. · Model EGN0B101-1 · UDI-DI 14719882250887
5
510(k) clearances
7
Adverse events (1 deaths)
1
Recalls
237
Facilities
Description
Copioumed's Examination gown is a device for medical purposes, made of SMS material, that is draped or worn by the patient as a body covering during medical examinations. Provides patient protection from contamination by microorganisms, body fluids and particles.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-12-23 | Encompass Group LLC | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. |
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Get your free API keyRead the docsData 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.