2 results
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7ms
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Sources: EU EUDAMED, US FDA
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
FDA Enforcement
Class II
·Terminated·Mani, Inc. - Kiyohara Facility·May 3, 2023
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016