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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, hand, calculus removal
Product CodeELA
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2015 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Component Falling 1 1
Fail-Safe Design Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Discomfort 1 1
Laceration(s) 1 1
Pain 1 1

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