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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wound retraction and protection system
Definition A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
Product CodePQI
Regulation Number 878.4371
Device Class 2