NA

Primary DI
00841983102547
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
NE-432B
Catalog number
NE-432B
Device description
Electrode Jumpers, NE-132B
Published
2016-09-19
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
IKNElectromyograph, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKNElectromyograph, DiagnosticPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983102547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983102547008419831025478419831025470841983102547

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20763000886794N/aMEDTRONIC XOMED, INC.IKN2025-06-23
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00195377099013PULSENuvasive, Inc.IKN2023-07-06
00190376459028SafeOpALPHATEC SPINE, INC.IKN2023-02-12
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00853818007477MyoVision SoftwarePRECISION BIOMETRICS INCIKN2022-11-10
00195377049193PULSENuvasive, Inc.IKN2022-05-06
00195377058508PULSENuvasive, Inc.IKN2022-05-06
00195377060716PULSENuvasive, Inc.IKN2022-05-06
00195377061379PULSENuvasive, Inc.IKN2022-05-06
00195377065544PULSENuvasive, Inc.IKN2022-05-06
00195377081636PULSENuvasive, Inc.IKN2022-05-06
00840067103616Cascade IOMAXCADWELL INDUSTRIES, INC.IKN2021-10-15
00382830042369NatusNATUS NEUROLOGY INCORPORATEDIKN2021-07-20
00887517070708NVM5Nuvasive, Inc.IKN2021-06-15
00887517075383NVM5Nuvasive, Inc.IKN2021-06-15
00887517091994NVM5Nuvasive, Inc.IKN2021-06-15
00887517097958NVM5Nuvasive, Inc.IKN2021-06-15
00887517320919NVM5Nuvasive, Inc.IKN2021-06-15
00841983104251Neuropack S3NIHON KOHDEN AMERICA, INC.IKN2020-07-20
00841983104268Neuropack S3NIHON KOHDEN AMERICA, INC.IKN2020-07-20
00190376180359SafeOpALPHATEC SPINE, INC.IKN2019-12-31
00190376192277SafeOpALPHATEC SPINE, INC.IKN2019-12-31
00887517048646NVM5Nuvasive, Inc.IKN2019-11-21
00887517075758NVM5Nuvasive, Inc.IKN2019-11-21
00887517075772NVM5Nuvasive, Inc.IKN2019-11-21
00887517090041NVM5Nuvasive, Inc.IKN2019-11-21
00887517990754PULSENuvasive, Inc.IKN2019-11-18