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The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.

The Utepreva Endometrial Sampler (UP01) is a single-use, sterile device designed to obtain endometrial cytological and histological samples. The device is an Rx device that functions as follows: The Utepreva Endometrial Sampler is gently inserted though the cervix into the uterus. The skirt (guard) will reach the cervix indicating to the clinician to stop inserting the device. The brush is then extended by pushing the handle until resistance is felt when the tip meets the fundus of the uterus. The sponge on the tip is intended to minimize the risk of piercing of the fundus by the tip of the brush and enables additional tissue sampling by absorption of the fluid and the cells from the uterus. The Utepreva Endometrial Sampler is rotated in a clockwise or counterclockwise manner for four or five 360° rotations. Upon completion of the rotations, the handle is pulled back so that the brush and tip are withdrawn into the outer sheath. The suction created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush, sponge and any fluid that was aspirated can then be immersed into the preservative solution to be used by the pathology lab. The device materials consist of polydimethylsiloxane, high density polyethylene, cyanoacrylate adhesive, Loctite, Permabond polyolefin primer, stainless steel, Nylon, polycarbonate, and polypropylene. The device is packaged in a Tyvek® pouch. One pouch is then packaged in a unit box. Fifteen unit boxes are packaged within a single master box to create the final shipped product.