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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device piston syringe lever
Definition Controlled compression of a piston syringe
Product CodeQBL
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
UROGEN PHARMA LTD
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Readings 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 2 2
Loss of consciousness 1 1

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