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Wound Retraction And Protection System

FDA product code PQI · 1 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4371
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2017-10-25 – 2017-10-25

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.

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