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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sealant, microbial
Definition Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.
Product CodeNZP
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Failure to Deliver 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3

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