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The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve. The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic. The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP <51> conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown. The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine. USP grade silver sulfadiazine is used. The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum. The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices. The subject devices are sterile single-use devices. Sterilization was performed.