FDA-Device2019-12-18Class II
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Hazard
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Sold states
US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK
Affected count
820
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0613-2020Don't want to check this manually?
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