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The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.

The PolyCatch Retrieval Device is intended for capture and retrieval of excised polyps, foreign bodies, tissue samples and calculi during flexible or rigid endoscopy procedures.

The PolyCatch Retrieval Device is a complete one-piece device for retrieval of polyps and foreign bodies from the gastrointestinal and respiratory tracts and is a disposable instrument intended for single patient use only. The PolyCatch Retrieval Device is used through the working channel of a legally marketed endoscope. The PolyCatch Retrieval Device consists of a handle, outer sheath and a snare wire/loop to which a non-Latex pouch is attached. As the snare wire is advanced from of the outer sheath of the device, it expands to its full circumference thereby deploying the non-Latex pouch. The pouch can then be manipulated by the clinician to engage a polyp or foreign body. After the polyp or foreign body is captured within the pouch the handle is used to draw the snare wire and pouch back against the device sheath. The endoscope along with the PolyCatch is then removed together from the patient to complete the retrieval procedure.

The SonoTip Pro and Pro Flex - TBNA Needle System is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The SonoTip Pro and Pro Flex EBUS-TBNA Needle System is a complete onepiece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. The SonoTip Pro Flex EBUS-TBNA Needle System is coupled to the working channel of a legally marketed ultrasound endoscope. The needle is then ultrasonically guided and imbedded into the desired target lesion for aspiration of the required biopsy sample. A 2-way stop-cock valve and self-locking aspiration syringe are supplied as procedural aids to provide suction to through the needle lumen and assist in sample acquisition.

The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.

The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.

The SonoTip II 25-gauge Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The Medi-Globe SonoTip II 25-gauge Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.

The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip II Endoscopic Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. A feature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This feature provides the user with the ability to precisely adjust the working length of the instrument relative to the endoscope being used.

The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.

The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumen models and allows incremental, rotational orientation of the distal catheter tip and cutting wire. Device models are compatible with either .021 or .035" guide wires and allow simultaneous injection of contrast medium during use.