AMI Agency for Medical Innovations GmbH AFC 100 A.M.I. FasciaCutter Disposable Instrument

The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.

The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload.

Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 Spheres per tray, 30 trays, 90 spheres total.

Set includes the following: Stryker Items: 3910-500-727 Suture Manipulator 3910-500-742 Suture Cutter 2mm 3910-500-739 Penetrating Grasper 45* 3910-500-738 Penetrating Grasper 30* 3910-500-737 Penetrating Grasper Str. 3910-500-736 Penetrating Grasper L 3910-500-735 Penetrating Grasper R 3910-500-850 5mm Probe x2 3910-500-733 Tissue Liberator Blade Up 3910-500-734 Tissue Liberator Blade Down 3910-500-732 Rasp Down Bend Arthrex Items: AR-13970SR KingFisher Suture Retriever/Tissue Grasper with SR Handle AR-13974SR FiberTape Retriever with SR Handle, Self-Ratcheting AR-11794L Suture Cutter, 4.2 mm, Open-End, Left Notch (Used w/ All Suture) AR-13250 FiberTape Suture Cutter

HEP IR 4-7MM 38CM RS X 45CM USPropaten Vascular Graft with Integrated Rings

SCRW,CANN. INT.,W/DISP SHTH

Burr, Oval, 10 flute, 3.0mm

The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

The Ellipsys Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables that are packaged together, and referred to as the Ellipsys Vascular Access Kit. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.

The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneouslycut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX 45 Powered Plusinstruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freelyin both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operativesite.The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements fordisposing of the battery pack. Refer to the Battery Pack Disposal section.The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple legpoints during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used or improperly installed reloadfrom being refired or an instrument from being fired without a reload.

Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 Spheres per tray, 30 trays, 90 spheres total.