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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

Device Problems
Deflation Problem 57
Balloon 29
Device Operates Differently Than Expected 17
Material Rupture 13
Difficult to Remove 3
Burst Container or Vessel 1
Material Separation 1
Inflation Problem 1
Total Device Problems 122


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