Home GUDID 00190376549408 SafeOp 3
Primary DI 00190376549408
Brand SafeOp 3
Company ALPHATEC SPINE, INC.
Model AIX1351-S
Device description SafeOp 3 MEP Activator, Sterile
Published 2024-07-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GWF Stimulator, electrical, evoked response
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWF Stimulator, Electrical, Evoked Response Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190376549408 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190376549408 00190376549408 190376549408 0190376549408
GMDN Terms# Term, Definition table Term Definition Neurophysiologic monitoring system An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.
Regulatory Flags# DUNS number 602465783 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B006NVHS102 NONE Neurovision Medical Products, Inc. GWF 2025-12-18 08056446900338 NeMus 2 600 EB NEURO SPA GWF 2025-05-26 08056446900345 NeMus 2 700 EB NEURO SPA GWF 2025-05-26 08056446900352 NeMus 2 + EB NEURO SPA GWF 2025-05-26 08056446901106 NExT-DOCKING EB NEURO SPA GWF 2025-05-22 08056446901113 NExT-PAD EB NEURO SPA GWF 2025-05-22 08056446901120 NExT-AMP-ADVANCED EB NEURO SPA GWF 2025-05-22 08056446901137 NExT-HS EB NEURO SPA GWF 2025-05-22 08056446901168 NExT-AMP EB NEURO SPA GWF 2025-05-22 08056446901199 NExT-AS EB NEURO SPA GWF 2025-05-22 08056446901205 NExT Station EB NEURO SPA GWF 2025-05-22 08056446901090 NExT Station Advanced EB NEURO SPA GWF 2025-05-19 00190376530024 SafeOp 3 ALPHATEC SPINE, INC. GWF 2024-11-12 B006NVPTKITC3P6WSF52 Nerveana+® Neurovision Medical Products, Inc. GWF 2024-02-01 B006NVPTKITC3P7WSF52 Nerveana+® Neurovision Medical Products, Inc. GWF 2024-02-01 B006NVPTKITC3P8WSF52 Nerveana+® Neurovision Medical Products, Inc. GWF 2024-02-01 B006NVPTST2 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-12-04 B006NVPTKITC3P652 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPTKITC3P6T52 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPTKITC3P752 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPTKITC3P7T52 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPTKITC3P852 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPTKITC3P8T52 Nerveana+® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P6D52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P6T52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P7D52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P7T52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P8D52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVTKITC3P8T52 Nerveana® Neurovision Medical Products, Inc. GWF 2023-04-20 B006NVPIC61 Nerveäna+® Neurovision Medical Products, Inc. GWF 2023-04-11
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