FDA.reportPublic FDA data

NA

Primary DI
00841983103063
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
JS-102B
Catalog number
JS-102B
Device description
Stimulation Pod, Low, 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
GYCELECTRODE, CORTICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983103063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983103063008419831030638419831030630841983103063

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
00650551006114CORTAC®PMT CORPORATIONGYC2026-05-18
00650551005858CORTACPMT CORPORATIONGYC2026-05-15
00650551005902CORTACPMT CORPORATIONGYC2026-05-15
00650551005964CORTAC®PMT CORPORATIONGYC2026-05-15
00840067103029ZenithCADWELL INDUSTRIES, INC.GYC2025-12-31
00848530106195Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
10848530106192Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
00850011306338ATLAS Stim Headbox - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306345ATLAS Stim Headbox - High DensityNEURALYNX, INC.GYC2025-06-11
00850011306703ATLAS Stim Headbox SoftwareNEURALYNX, INC.GYC2025-06-11
00850011306710Fiber Optic Connector 2mNEURALYNX, INC.GYC2025-06-11
00850011306727Fiber Optic Connector 7mNEURALYNX, INC.GYC2025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNEURALYNX, INC.GYC2025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityNEURALYNX, INC.GYC2025-06-11
00867718000285ATLAS Stim Headbox - NKNEURALYNX, INC.GYC2025-06-11
00848530106249Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
10848530106246Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
00848530093693Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-05-19
00650551005445CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005452CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005469CORTAC®PMT CORPORATIONGYC2025-04-25
00650551005476CORTAC®PMT CORPORATIONGYC2025-04-25
00650551000884CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002178CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002840CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002918CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003052CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003069CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003144CORTAC®PMT CORPORATIONGYC2025-03-17