FDA-Device2015-06-17Class II
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
Gyrus Acmi, Incorporated
Hazard
Potential lack of sterility assurance.
Sold states
Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Affected count
12,020 boxes
Manufactured in
136 Turnpike Road, N/A, Southborough, MA, United States
Products
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1752-2015Don't want to check this manually?
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