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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, spinal, short term
Regulation Description Anesthesia conduction needle.
Product CodeMIA
Regulation Number 868.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
EPIMED
  SUBSTANTIALLY EQUIVALENT 1
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 11
Entrapment of device or device component 2
Difficult to remove 2
Material separation 1
Defective item 1
Manufacturing or shipping issue associated with device 1
Positioning Issue 1
Protective measure issue 1
Hole in material 1
Product quality issue 1
Component(s), broken 1
Total Device Problems 23

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