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PosiSep C

HEMOSTASIS, LLC · Model 9210754 · UDI-DI 00858439001385

EMXLYA Prescription
1
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
50
Facilities

Description

PosiSep C devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.

Recalls

DateFirmReason
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised

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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.