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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biliary stent, drain, and dilator accessories
Definition Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.
Product CodeQGE
Regulation Number 876.5012
Device Class 1