FDA.reportPublic FDA data

NA

Primary DI
04931921900970
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
BM-122B
Catalog number
BM-122B
Device description
tcMEP Stimulation Cable, 10m
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142624000Neuromaster G1 MEE200Nihon Kohden Corporation2015-04-24GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921900970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921900970049319219009704931921900970

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags#

DUNS number
690568050
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04931921049464NAMDI-1000MDI-10002026-05-20
04931921111697NAIF-949PIF-949P12026-05-20
14931921057541cap-ONEYG-213TYG-213T-A12026-04-20
04931921877401BluPRO®TL-601T0P3112026-02-03
14931921010232cap-ONEYG-220TYG-220T2023-05-22
14931921010270cap-ONEYG-221TYG-221T2023-05-22
14931921010300cap-ONEYG-230TYG-230T2023-05-22
14931921010331cap-ONEYG-231TYG-231T2023-05-22
14931921044350cap-ONE`YG-211TYG-211T-A12024-06-21
04931921025727cap-ONETG-980P1TG-980P12022-05-12
14931921838195NAYG-101TYG-101T2016-09-05
14931921869038cap-ONEYG-122TYG-122T2016-09-05
14931921877996NAYG-111TYG-111T2016-09-05
14931921883713cap-ONEYG-125TYG-125T2016-09-05
14931921883744cap-ONEYG-135TYG-135T2016-09-05
14931921885694NAYG-211TYG-211T2016-09-05
14931921886202cap-ONEYG-232TYG-232T2016-09-05
14931921890025NAYG-213TYG-213T2016-09-05
14931921895709cap-ONEYG-242TYG-242T2016-09-05
14931921899295NAYG-214TYG-214T2016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
00190376530024SafeOp 3ALPHATEC SPINE, INC.GWF2024-11-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTST2Nerveana+®Neurovision Medical Products, Inc.GWF2023-12-04
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P7T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P852Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPIC61Nerveäna+®Neurovision Medical Products, Inc.GWF2023-04-11