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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, carbon-dioxide, uterotubal (and accessories)
Regulation Description Uterotubal carbon dioxide insufflator and accessories.
Product CodeHES
Regulation Number 884.1300
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2025 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Hematoma 1 1
Insufficient Information 1 1

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