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Gyrus ACMI

Gyrus ACMI, LLC · Model 7089-0838 · UDI-DI 00821925034945

EMX Prescription
1
510(k) clearances
102
Adverse events (2 deaths)
4
Recalls
53
Facilities

Description

Blu D-Style Anatomical Nasal Pack, 8.0 cm x1.5 cm x 3.0 cm, Bacteriostatic

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.