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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound cleaner, ultrasound
Definition The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound
Product CodeNRB
Regulation Number 878.4410
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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