FDA Device Intelligence
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Ultracell®

Beaver-Visitec International, Inc. · Model NS20210-C · UDI-DI 30886158012253

EMX
10
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
51
Facilities

Description

***NON-STERILE*** SINUS PACK W/STRING- 3.5CM X 1.2CM X 1.2CM (1000/SP)

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.