FDA.reportPublic FDA data

NA

Primary DI
04931921103166
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
JS-101B
Catalog number
JS-101B
Device description
Stimulation Pod, High, MEE-1000
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04931921103166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04931921103166049319211031664931921103166

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04931921877401BluPRO®TL-601T0P3112026-02-03
04931921044353cap-ONE`YG-211TYG-211T-A12024-06-21
04931921017524NAZR-920PZR-920P-FT2024-01-25
04931921017159CNS-2101 Central MonitorCNS-2101CNS-21012023-10-30
04931921007723Nihon Kohden, EEG-1200A Series NeurofaxKD-029A-01KD-029A-012019-07-24
04931921007730Nihon Kohden, EEG-1200A Series NeurofaxKE-122A-01KE-122A-012019-07-24
04931921017166CNS-2101 Central MonitorCNS-2101CNS-21012023-10-01
04931921010235cap-ONEYG-220TYG-220T2023-05-22
04931921010273cap-ONEYG-221TYG-221T2023-05-22
04931921010303cap-ONEYG-230TYG-230T2023-05-22
04931921010334cap-ONEYG-231TYG-231T2023-05-22
04931921007631Nihon Kohden, EEG-1200A Series NeurofaxJE-921A-01JE-921A-012019-07-24
04931921007709Nihon Kohden, EEG-1200A Series NeurofaxLS-703A-01LS-703A-012019-07-24
04931921007716Nihon Kohden, EEG-1200A Series NeurofaxLS-706A-01LS-706A-012019-07-24
04931921025727cap-ONETG-980P1TG-980P12022-05-12
04931921005828BluPRO®TL-271T3TL-271T3-A242022-04-06
04931921000045Smart Cable NMT Module and AccessoriesDH-101PDH-101P2021-09-27
04931921002018Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-151RCU-151R2021-09-27
04931921002056Nihon Kohden Life Scope G5 Bedside Monitoring SystemCU-152RCU-152R2021-09-27
04931921002087N/AAA-174PAA-174P2021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.GWF2026-03-24
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00810155862602NONENeurovision Medical Products, Inc.GWF2025-12-19
00810155862626NONENeurovision Medical Products, Inc.GWF2025-12-19
00810155862640NONENeurovision Medical Products, Inc.GWF2025-12-19
B006NVHS1021NONENeurovision Medical Products, Inc.GWF2025-12-18
04250307611959N/Ainomed Medizintechnik GmbHGWF2025-05-02
06430063200187Nexstim NBS SystemNEXSTIM, INC.GWF2025-04-01
05060229530868Magstim Double 70mm Air Film CoilTHE MAGSTIM COMPANY LIMITEDGWF2025-02-19
B006NVPS2Nerveäna+®NEUROVISION MEDICAL PRODUCTS, INC.GWF2025-02-11
00382830032759NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830032872NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
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00382830045070NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830045087NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046916NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046930NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046947NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830051385NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830053082NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830059374NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06