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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device brush, biopsy, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGEE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Esophagus 2 2
Hemorrhage/Bleeding 1 1

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