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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
Regulation Description 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

MDR Year MDR Reports MDR Events
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1

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

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