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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, deployment balloon
Definition The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Product CodeOQL
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 1 1

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

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