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ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.

FLOW NOW is intended for monitoring blood flow in vessels. FLOW NOW is indicated for monitoring blood flow in peripheral vessels during and following reconstructive microvascular procedures, re-implantation, and free flap transfers. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days postoperatively.

The GEM FLOW NOW (FLOW NOW) device is comprised of an implantable non-active silicone vessel sleeve (Figure 2), a 20 MHz ultrasonic Doppler transducer (probe) and probe wire, suture sleeve, probe connector, and an external lead that connects to a monitor. FLOW NOW has a soft, pliable silicone "vessel sleeve" that retains the Doppler probe via press-fit into a silicone bore. The device comes with vessel sleeve and probe already assembled. The FLOW NOW Device is intended for monitoring blood flow in vessels. It is indicated for monitoring blood flow in peripheral vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW NOW Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively. The FLOW NOW device is intended for use with both currently cleared FLOW COUPLER Monitors (GEM1020M and GEM1020M-2). The probe is removed from the patient 3 to 14 days after implantation, once monitoring is complete. The probe is separated from the vessel sleeve and removed from the patient's body. non-invasively, by the surgeon pulling on the probe wire outside the patient's body. The silicone vessel sleeve remains permanently implanted. The FLOW NOW device can be used to monitor blood flow through veins and arteries ranging from 2.0 to 4.0 mm in outside diameter.

GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis. The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow. The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below: 1. FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead. 2. FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.

The VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.

Two accessory devices comprise the Vessel Everter System: Vessel Everter and Sizing Guide. The Vessel Everter system is an accessory device to the GEM FLOWCOUPLER System, a pair of implantable rings that are used for end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The Vessel Everter System are two non-implantable, sterile, single use hand-held devices that facilitate sizing and use of the GEM FLOWCOUPLER System. The Vessel Everter is comprised of a handle with two soft silicone end effectors (tips), one on each end. The instrument handle features two separate silicone end effectors, each of a different size, intended to be used at the surgeon's discretion. The Vessel Everter end effector is designed with a narrowing tip to allow for engagement with multiple sizes of vessels, corresponding with a coupler size of 2.0-4.0 mm rings. The Vessel Everter is used to press vessel tissue onto the GEM FLOWCOUPLER rings. To accomplish this, the surgeon presses the Vessel Everter into the tissue, flaring the tissue onto and over the Coupler locking pins. The Sizing Guide is a hard, plastic handle featuring holes on either end through which the vessel's outer diameter may be measured. The holes' diameters are intended to match the inner diameters of the various GEM FLOWCOUPLER rings. The holes correlate to vessel diameters of 2.0 mm to 4.0 mm in 0.5 mm increments. The surgeon may use the sizing guide to guide the selection of which coupler they will use for each particular anastomosis. The Sizing Guide is used by placing the vessel on the sizing guide and comparing the vessel diameter to the holes in the Sizing Guide. The Vessel Everter and Sizing Guide are sterilized by ethylene oxide and are provided sterile for-single-patient use. The Vessel Everter and Sizing Guide are not implantable and are disposed of after single use. The parent device, GEM FLOWCOUPLER System, remains unchanged and is not addressed in this submission.

The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post- operatively.

The FLOW COUPLER Device and System consists of a FLOW COUPLER Device and a FLOW COUPLER Monitor. The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. The FLOW COUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FLOW COUPLER rings, and an external lead. The probe via the external lead connects to the monitor and emits a pulsed ultrasonic signal. A varying audible signal is produced when the probe detects flow.

The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.

The device is a sterile (gamma irradiation), single-use, implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each of the ring. A probe-holder feature is molded on each of the paired rings to be a point of attachment for a sensor/probe at the site of anastomosis.