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The intended use of the device is to allow the physician to increase the stiffness of the enteroscope when additional rigidity is required.

Do not use this product for any other purposes.

The product consists of a nitinol wire of specific diameter and length that is centerless ground to create a tapered distal end that terminates in a ball tip. The tapered distal end is meant to provide added flexibility to the product for ease of insertion into the endoscope, as well as reduced resistance to bending the angulation of the scope tip while in use. There is a metal tag at the proximal end of device that is use for gripping the device and setting the insertion length in the working channel of the endoscope. The tag will also contain markings that identify the company name (Fujifilm), model number, dimensions, and Unique Device Identifier (UDI). The tag is assembled to the nitinol wire via mechanical means, such as a set screw that cannot be loosened or removed. The product will be packaged and sold in a non-sterile state.

The stiffening wire is designed to be contained within the endoscope instrument channel and not to protrude from the distal tip of the endoscope during use.

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