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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic storage cover
Definition To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Product CodeOCU
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH ENDOSCOPY LTD
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Positioning Failure 1 1
Device Slipped 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

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