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The Coated Electrosurgical Electrodes are intended for the following indications: Cutting of Soft Tissue, Coagulation of Soft Tissue.

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The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.

The Electrosurgical Pencils are for the cutting and coagulation of soft tissue and have a 3-pin connector attached to a 10 foot conductive cable and are designed for use with standard electrosurgical generators (ESU). The connector or plug fits into the monopolar side of a standard electrosurgical unit. The handpieces are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencil that is connected to the generator by means of an adapter activated by a monopolar footswitch. One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode. The Holster is intended to store the pencil while it is not actively in use that attaches to a surgical drape and avoids accidental activation when not in use The Tip Cleaner is intended to be used for eschar removal that tends to build up on an uncoated electrode by gently scraping it along the aggressive surface. The Tip Cleaner attaches to a surgical drape by an adhesive backing. The Coated Electrode is an electrode use to cut and coagulate soft tissue coated with a material intended to reduce the build up of eschar usually eliminating the need for a Tip Cleaner. Pencils packaged with Coated Electrodes will not have a Tin Cleaner.

These electrosurgical devices are designed for cutting of soft tissue and coagulation.

The unimed Coated Laparoscopic Electrode, unimed Coated Arthroscopy Electrode and the unimed Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. These electrosurgical devices are designed for cutting of soft tissue and coagulation. The electrodes are available in a variety of diameters, lengths and tip configurations. The electrodes are available sterile, single use only.

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The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue. unimed Surgical Products intends to market the unimed Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The unimed Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.

The unimed Coated Electrodes are indicated for use in the cutting and coagulation of soft tissue.

The Coated Electrodes are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Emralon and Teflon are non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. The Coated Electrosurgical Electrodes are available in a variety of tip configurations and lengths. The tip configurations include blades, needles, and balls. The blades and needles are also available with the tips only partially exposed. These devices are designed to cut and coagulate soft tissue during surgical procedures. The entire line of electrodes will fit all button, rocker, and footcontrolled pencils. The electrodes are available sterile, single use only.