FDA.reportPublic FDA data

NA

Primary DI
00841983103056
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
JS-101B
Catalog number
JS-101B
Device description
Stimulation Pod, High, MEE-1000
Published
2016-09-19
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
GYCELECTRODE, CORTICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
GYCElectrode, CorticalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983103056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983103056008419831030568419831030560841983103056

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
021063219
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841983101493NAYG-101TYG-101T2016-09-19
10841983101509NAYG-111TYG-111T2016-09-19
10841983101516cap-ONEYG-122TYG-122T2016-09-19
10841983101523NAYG-211TYG-211T2016-09-19
10841983101530NAYG-213TYG-213T2016-09-19
10841983101547NAYG-214TYG-214T2016-09-19
10841983101554cap-ONEYG-232TYG-232T2016-09-19
10841983101561cap-ONEYG-242TYG-242T2016-09-19
10841983102766cap-ONEYG-125TYG-125T2016-09-19
10841983102773cap-ONEYG-135TYG-135T2016-09-19
10841983102780cap-ONEYG-225TYG-225T2016-09-19
10841983102797cap-ONEYG-235TYG-235T2016-09-19
00841983100673NAJG-900PJG-900P2016-09-19
00841983101434NATG-101TTG-101T2016-09-19
00841983102295NAOLG-2800AOLG-2800A2016-09-19
00841983102622NATG-900PTG-900P2016-09-19
00841983102639cap-ONETG-920PTG-920P2016-09-19
00841983102646cap-ONETG-921T3TG-921T32016-09-19
00841983102653cap-ONETG-970PTG-970P2016-09-19
10841983101592NAYG-921PYG-921P2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B006LTE7003PMD52Cobra®Neurovision Medical Products, Inc.GWF2023-04-06
B006LTE7003PSD52Cobra®Neurovision Medical Products, Inc.GWF2023-04-06
B006LTE7003PLD52Cobra®Neurovision Medical Products, Inc.GWF2023-03-20
B006LTE7003PL52CobraNeurovision Medical Products, Inc.GWF2020-08-12
B006LTE7003PLT52CobraNeurovision Medical Products, Inc.GWF2020-08-12
B006LTE7003PM52CobraNeurovision Medical Products, Inc.GWF2020-08-12
B006LTE7003PMT52CobraNeurovision Medical Products, Inc.GWF2020-08-12
B006LTE7003PS52CobraNeurovision Medical Products, Inc.GWF2020-08-12
B006LTE7003PST52CobraNeurovision Medical Products, Inc.GWF2020-08-12
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWF2020-05-25
08056446900208NeMus SYSTEMEB NEURO SPAGWF2019-05-24
08056446900215NeMus PC PERIPHERALEB NEURO SPAGWF2019-05-24
08056446900222NeMus 1EB NEURO SPAGWF2019-05-24
08056446900239NeMus 1EB NEURO SPAGWF2019-05-24
08056446900246Power-LAN Connection BoxEB NEURO SPAGWF2019-05-24
08056446900260R-KEY (Dedicated Keyboard)EB NEURO SPAGWF2019-05-24
08056446900253Power-LAN Connection Box USBEB NEURO SPAGWF2019-04-10
08056446900369NeMus 2EB NEURO SPAGWF2019-04-10
08056446900376NeMus 2EB NEURO SPAGWF2019-04-10