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 Operators 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-0637-2020Don't want to check this manually?
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