FDA-Device2019-04-24Class II
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Gyrus ACMI, Inc.
Hazard
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Sold states
Nationwide Foreign: Germany,Japan, Singapore
Affected count
82
Manufactured in
2925 Appling Rd, N/A, Bartlett, TN, United States
Products
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1181-2019Don't want to check this manually?
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