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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wound drain catheter system
Regulation Description Powered suction pump.
Definition For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Product CodeOTK
Regulation Number 878.4780
Device Class 2

Device Problems
Mechanical jam 1
Detachment of device or device component 1
Torn material 1
Material puncture 1
Total Device Problems 4

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