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Surgical Film

FDA product code OOD · 11 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.3300
Review panel
SU
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2007-04-13 – 2024-04-09

To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.

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