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The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.

The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion. The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.

The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Medline ReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.