Correction includes all lots of products distributed between January 2007 and March 2015. P/N: 9734240,Nav 6.5mm Tap (Cannulated),9734239, Nav 5.5mm Tap (Cannulated), 9734238,Nav 4.5mm Tap (Cannulated), 9734302,6.5mm Tap (Cannulated),9734300,5.5mm Tap (Cannulated),9734298,4.5mm Tap (Cannulated),9734303,7.5mm Tap (Cannulated),9734301,6.0mm Tap (Cannulated),9734299,5.0mm Tap (Cannulated),9734304,8.5mm Tap (Cannulated),9730944,4.5 mm Cannulated Tap,9730945,5.5 mm Cannulated Tap,9730946,6.5 mm Cannulated Tap,9733182,4.0 mm Cannulated Tap, 1.86P,9733183,4.5 mm Cannulated Tap,9733184,4 mm Cannulated Tap, 1.5P, UCSS,960-347,7.5 Old Round APT (Cannulated Tap-Tip only),960-345,6.5 Old Round APT (Cannulated Tap-Tip only),960-344,5.5 Old Round APT (Cannulated Tap-Tip only) The above referenced cannulated taps are included in the kits and,9731921,KIT 9731921 INSTRUMENT SPINE BASIC,9735101,INST KIT 9735101 TAP ASM 4.5 G5, 9735102,INST KIT 9735102 TAP ASM 5.5 G5,9735103,INST KIT 9735103 TAP ASM 6.5 G5,9735107,INST KIT 9735107 TAP ASM 5.0 G5,9735108,INST KIT 9735108 TAP ASM 6.0 G5,9735109,INST KIT 9735109 TAP ASM 7.5 G5,9735149,INST KIT 9735149 CANNULATED 6.5MM TAP,9735150,INST KIT 9735150 CANNULATED 5.5MM TAP,9735151,INST KIT 9735151 CANNULATED 4.5MM TAP,9735168,INST KIT 9735168 4MM TAP 1.86P,9735169,INST KIT 9735169 4.5MM CANN TAP,9735170,INST KIT 9735170 4MM TAP 1.5P,9734490,INST SET 9734490 LEGACY,9734491,INST SET 9734491 SOLERA STD,9734492,INST SET 9734492 SOLERA DEF UPGRADE,9735469,TAPS 9735469 CD HORIZON SOLERA,9734631,TD SET 9734631 LEGACY STD TAPS/DRIVERS,9734632,TD SET 9734632 SOLERA STD TAPS/DRIVERS,9733370,VERTEX MAX SET, 9733370, NAVIGATED,9734838,KIT 9734838 SOLERA 8.5 CANNULATED TAP,
Medtronic Navigated Cannulated Taps || Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. || Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.
Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM
Descripción del producto
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L || The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure. The Camino catheter has a miniature transducer at the distal tip. This design eliminates the need for a fluid-filled system to carry pressure waves to an external transducer and thus, the problems inherent in such fluid-filled systems are eliminated. The Camino catheter is packaged with a zero adjustment tool which allows for the adjustment of the transducer during catheter preparation, and the LICOX Bolt Adapter Fitting. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma is clinically important. It is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Descripción del producto
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. || Product Usage: || Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Descripción del producto
iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue
NEURO PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
NEURO SPINE PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Worldwide Distribution - US (nationwide) and Canada.
Descripción del producto
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Worldwide Distribution - US (nationwide) and Canada.
Descripción del producto
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
NEURO PACK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
Descripción del producto
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
Serial Numbers A1221, A1226 (Ship Date 07/2015); Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015); Serial Number A1246 (Ship Date 04/2015); Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015); Serial Number A1225 (Ship Date 01/2015); Serial Numbers A1241, A1242 (Ship Date 12/2014); Serial Number A1036 (Ship Date 11/2014); Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014); Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014); Serial Number A1227 (Ship Date 08/2014); Serial Number A1223 (Ship Date 07/2014); Serial Numbers A1218, A1220 (Ship Date 06/2014); Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014); Serial Numbers A1214, A1064 (Ship Date 03/2014); Serial Numbers A1087, A1213 (Ship Date 01/2014); Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013; Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013); Serial Numbers A1022, A1044 (Ship Date 10/2013); Serial Number A1059 (Ship Date 09/2013); Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013); Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013); Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013); Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013); Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013); Serial Number P11 (Ship Date 02/2013); Serial Number P-7 (Ship Date 11/2012); Serial Numbers A1013, P-8 (Ship Date 09/2012); Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .
Descripción del producto
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. || The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
Catalog Number: 9001300 || NEURO-SPINE SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number: 9002256 || NEUROSURGERY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization || The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
US Nationwide Distribution in the states of CA ,CO, OH, OR
Descripción del producto
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm || 18 gauge, 10 mm active tip || Model Number: C-1010-R-18 || Product Usage: || The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Descripción del producto
American Surgical Delicot 15mm x 20mm || Ref: 63-04 || Product Usage: || Neurosurgical and Nonneurosurgical Sponges