Short Overview

The ENDOPATH™ ETS45 Articulating Endoscopic Linear Cutter and Reloads are intended for transection, resection, and/or creation of anastomoses. The ENDOPATH™ ETS45 Linear Cutters are sterile, single-patient-use instruments that deliver staples while simultaneously dividing tissue between rows. The instruments’ safety lockout feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Do not load the instruments more than eight times for a maximum of eight firings per instrument. The use of the instrument with staple line buttressing material may reduce the number of firings. Use only the indicated reloads in the ETS45 instrument. Do not use ETS45 reloads in an instrument other than an ETS45 instrument. The devices are intended for use by or under the direct supervision of a physician within a sterile field/setting (e.g., operating room, surgical center). The clinical benefit of the ENDOPATH™ ETS45 Articulating Endoscopic Linear Cutter is to assist in transection, resection, and the creation of anastomoses during surgical procedures.

One or more non-implantable components of this device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Material Present Residual Risk Cobalt: CAS No. 7440-48-4 EC No. 231-158-0 Current scientific evidence supports that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. The footnote adjacent to the above symbol on the packaging refers to the relevant Material Present

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