SEARCH RESULTS FOR: (*Yuzhnyy federal*)(137 results)

DEVICE DESCRIPTION The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system PACKAGING CONTENTS A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion. INDICATIONS FOR USE The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination DIRECTIONS FOR USE Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure CONTRAINDICATIONS The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques WARNINGS Contents supplied sterile. Do not use if sterile barrier is damaged Do not use the GreenEgg™ if the device has been opened or damaged CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician STORAGE Store at room temp, avoid extreme temps DISPOSAL Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices REUSE PRECAUTION STATEMENT For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.

The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system. The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring. Medical Device Info. • Class II (enforcement discretion) medical device • Regulation: Oximeter, 870.2700 • Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence – Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence – Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II

Our Chest Tube Insertion Kit is carefully packed and vacuum-sealed contains the tools needed in emergency situations to perform chest intubation. This product is available for U.S. Military and Federal Civilian Government Sales only.

Our Chest Tube Insertion Kit is carefully packed and vacuum-sealed contains the tools needed in emergency situations to perform chest intubation. This product is available for U.S. Military and Federal Civilian Government Sales only.

Our Chest Tube Insertion Kit is carefully packed and vacuum-sealed contains the tools needed in emergency situations to perform chest intubation. This product is available for U.S. Military and Federal Civilian Government Sales only.

The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set. Note: Federal law (US) restricts this device to sale by or on the order of a physician.

Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing.

Vaginal Speculum, Lighted, Sterile, Size Medium, 25/box, 4 boxes/case Disposal Methods: Disposal practices must be in compliance with all Federal, State and Local laws and regulations. DO NOT DUMP INTO ANY SEWERS, ON THE GROUND OR INTO ANY BODY OF WATER.