Certificate number:
MD 670368
Scope: The manufacture (labeling) and distribution of devices in the areas of cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Neurology (including Neurovascular), Gynecology, Urology, Radiology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures), and Embolic Protection. These products include: Biliary stents, cardiovascular stents, ureteral stents, pancreatic stents, angiographic catheters, drainage catheters, introducer catheters, urological catheters, percutaneous catheters, ablation catheters, and guide catheters, biliary devices, electrosurgical instruments and generators, software for generators, retrieval devices, feeding devices, cannulas, endoscopes, examination gloves, irrigation/drainage devices and sets, Fluid circulations pumps, fluid administration, filling and infusion devices, inflators, ligators, dilators, connecting tubes, access sheaths, tubing sets, adaptors, left atrial appendage (LAA) closure devices and accessory devices, percutaneous access needles, aspiration needles, injection needles, introducer needles, endotherapy electrode system, radiofrequency ablation system, systems and accessory devices, surgical meshes, sutures and suturing devices, syringes, vascular introducers, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, endoscopic valves, endoscope channel support kits, cuff kits, biopsy caps, locking devices, bladder evacuators, sphincterotomes, embolic protection systems, ultrasound imaging catheters, retrieval sheaths, diagnostic software and recording systems, diagnostic mapping, pacing and recording catheters inclusive of accessory devices, pericardiocentesis kits, cables and minimally invasive tissue and thrombus removal devices, electrophysiology recording and mapping systems, including refurbishment, and software inclusive of accessory devices.
Distribution of penile prosthesis, implants for continence, accessories, and surgical tools, fiber optic laser delivery devices. Distribution of medical laser systems.
The installation of peripheral intervention systems (including minimally invasive tissue and thrombus removal devices) and ultrasound imaging systems and service (software upgrades and updates) of capital equipment.
Certificate number:
MDSAP 672104
Scope: The manufacture (labeling) and distribution of devices in the areas of cardiovascular (including Cardiovascular Interventions), Peripheral (including Peripheral Interventions), Electrosurgical Applications (including Electrophysiology), Gastroenterology, Nephrology, Neurology (including Neurovascular), Gynecology, Urology, Radiology, Endoscopy, Biliary, General Surgery (including Minimally Invasive Surgical Procedures), and Embolic Protection. These products include: Biliary stents, cardiovascular stents, ureteral stents, pancreatic stents, angiographic catheters, drainage catheters, introducer catheters, urological catheters, percutaneous catheters, ablation catheters, and guide catheters, biliary devices, electrosurgical instruments and generators, software for generators, retrieval devices, feeding devices, cannulas, endoscopes, examination gloves, irrigation/drainage devices and sets, Fluid circulations pumps, fluid administration, filling and infusion devices, inflators, ligators, dilators, connecting tubes, access sheaths, tubing sets, adaptors, left atrial appendage (LAA) closure devices and accessory devices, percutaneous access needles, aspiration needles, injection needles, introducer needles, endotherapy electrode system, radiofrequency ablation system, systems and accessory devices, surgical meshes, sutures and suturing devices, syringes, vascular introducers, nephrostomy devices, guidewires, biopsy devices, polypectomy devices, hemostasis devices, torque devices, endoscopic valves, endoscope channel support kits, cuff kits, biopsy caps, locking devices, bladder evacuators, sphincterotomes, embolic protection systems, ultrasound imaging catheters, retrieval sheaths, diagnostic software and recording systems, diagnostic mapping, pacing and recording catheters inclusive of accessory devices, pericardiocentesis kits, cables and minimally invasive tissue and thrombus removal devices, electrophysiology recording and mapping systems, including refurbishment, and software inclusive of accessory devices.
Distribution of penile prosthesis, implants for continence, accessories, and surgical tools, fiber optic laser delivery devices. Distribution of medical laser systems.
The installation of peripheral intervention systems (including minimally invasive tissue and thrombus removal devices) and ultrasound imaging systems and servicing (software upgrades and updates) of capital equipment.
