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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device staple, removable (skin)
Regulation Description Removable skin staple.
Product CodeGDT
Regulation Number 878.4760
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL MEDICAL LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 93
Failure to form staple 42
Replace 12
Misfire 7
Dislodged or dislocated 7
Failure to deliver 4
Difficult to deploy 3
Failure to deploy 2
Device Issue 2
Detachment of device component 2
Loose 2
Failure to align 2
Failure to fire 2
Detachment of device or device component 1
Device operates differently than expected 1
Defective item 1
No Information 1
No code available 1
Unknown (for use when the device problem is not known) 1
Defective component 1
Malfunction 1
Clips, scissored 1
Material erosion 1
Bent 1
Break 1
Component(s), broken 1
Slippage of device or device component 1
Sticking 1
System fails to activate 1
Twisting 1
Noise 1
Total Device Problems 198

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