Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7: 10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100 and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;
Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Descripción del producto
Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600.
Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Descripción del producto
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
Descripción del producto
Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
The products were shipped nationwide to medical facilities.
Descripción del producto
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Worldwide Distribution- USA and the countries of; Austria, Belgium, Denmark, France, Germany, Ile de la Reunion, Ireland, Israel, Italy, Japan, Marocco, Mexico, Netherlands, Ireland, Norway, Poland, Portugal, S. Korea, Slovenia, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.
Descripción del producto
Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX.
Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
Descripción del producto
Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
Nationwide and Internationally - Ireland, Korea, Mexico, The Netherlands, United Kingdom, Canada, Australia and Israel
Descripción del producto
Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS CORP 12740 San Fernando Rd. Sylmar, CA 91342 USA. The Precision Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable 16-output, multi-channel stimulator (IPG - Implantable Pulse Generator) with a rechargeable battery power source. The IPG, commonly implanted in the abdomen or buttock area (less frequently in the subclavicular area), can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. An externally used Charger is utilized to transcutaneously recharge the IPG (Implantable Pulse Generator) battery. Currently, Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For improved heat management, Charger 2.0 is equipped with thermistor (temperature sensing component), designed to activate/deactivate charging at a set temperature.
Catalog number: 903-430, Lot Numbers 148792, 149247; Catalog Number 903-435, Lot Numbers 147796, 148790; Catalog Number 903-440; and Lot Numbers 147795, 149246
Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.
Descripción del producto
Gravity Compensating Accessory; || High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. || Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; || distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 || The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.
All states in the United States including Puerto Rico. Australia, New Zealand, Canada, Andurra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, Tukey, United Kingdom.
Descripción del producto
Medtronic Accessory Kit , Titan¿ Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604
Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom