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Urgent FIELD SAFETY NOTICE Device: Santa Modular Reference: FSN1208 2012-12 Action: Advisory Attention: Perfusion System 8000 Chief of Perfusion, Director of Operating Room Services, Director of Biomedical
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Device SARNSTM Modular is a regulatory reporting requirement for medical device manufacturers and importers to report information about their devices to the regulatory authorities.
Medical device manufacturers and importers are required to file Device SARNSTM Modular.
Device SARNSTM Modular can be filled out online through the regulatory authority's portal. Manufacturers and importers need to provide detailed information about their devices, including product specifications, intended use, risk classification, and labeling.
The purpose of Device SARNSTM Modular is to ensure the regulatory authorities have accurate and up-to-date information about medical devices in the market. It helps in monitoring device safety, tracking adverse events, and enforcing regulatory compliance.
Device SARNSTM Modular requires reporting of various information, including device identification details, manufacturing information, risk assessment, clinical evidence, labeling, and adverse event reporting.
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