FDA.reportPublic FDA data

NA

Primary DI
00841983102462
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
JE-226AK
Catalog number
JE-226AK
Device description
Flat Pack Mini Expansion, Channel 65-128
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841983102462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983102462008419831024628419831024620841983102462

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021063219
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
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
10841983103947NAA/PA-9000ZA/PA-9000Z2016-09-24
10841983103954NAA/PA-9100ZA/PA-9100Z2016-09-24
10841983103930NAA/PA-1550ZA/PA-1550Z2016-09-24
00841983104336NK-HealthProtect Wireless Surge SolutionA-WSS-002-ZAA-WSS-002-ZA2021-12-23
10841983102667NATL-052STL-052S2016-09-19
10841983102674NATL-062STL-062S2016-09-19
10841983102704BluPRO®TL-271TTL-271T2016-09-19
10841983102711BluPRO®TL-271T3TL-271T32016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00650551003151CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003472CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003533CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003540CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003649CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003700CORTAC®PMT CORPORATIONGYC2025-03-17
00650551003731CORTAC®PMT CORPORATIONGYC2025-03-17