NA

Primary DI: 00841983100550
Brand: NA
Company: NIHON KOHDEN AMERICA, INC.
Model: JB-101B
Catalog number: JB-101B
Device description: Breakout Box
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

Related Records

Contact Domains

nkusa.com

Product Codes

Code	Name
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications

Code	Device	Specialty	Class
GWF	Stimulator, Electrical, Evoked Response	Neurology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00841983100550	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00841983100550	00841983100550	841983100550	0841983100550

GMDN Terms

Term	Definition
Neurophysiologic monitoring system	An 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.

Term

Definition

Neurophysiologic monitoring system

An 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

Contacts

Phone	Email
+1(800)325-0283	info@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: 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

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10841983101509	NA	YG-111T	YG-111T	2016-09-19
10841983101516	cap-ONE	YG-122T	YG-122T	2016-09-19
10841983101523	NA	YG-211T	YG-211T	2016-09-19
10841983101530	NA	YG-213T	YG-213T	2016-09-19
10841983101547	NA	YG-214T	YG-214T	2016-09-19
10841983101554	cap-ONE	YG-232T	YG-232T	2016-09-19
10841983101561	cap-ONE	YG-242T	YG-242T	2016-09-19
10841983102766	cap-ONE	YG-125T	YG-125T	2016-09-19
10841983102773	cap-ONE	YG-135T	YG-135T	2016-09-19
10841983102780	cap-ONE	YG-225T	YG-225T	2016-09-19
10841983102797	cap-ONE	YG-235T	YG-235T	2016-09-19
10841983103947	NA	A/PA-9000Z	A/PA-9000Z	2016-09-24
10841983103954	NA	A/PA-9100Z	A/PA-9100Z	2016-09-24
10841983103930	NA	A/PA-1550Z	A/PA-1550Z	2016-09-24
00841983104336	NK-HealthProtect Wireless Surge Solution	A-WSS-002-ZA	A-WSS-002-ZA	2021-12-23
10841983102667	NA	TL-052S	TL-052S	2016-09-19
10841983102674	NA	TL-062S	TL-062S	2016-09-19
10841983102704	BluPRO®	TL-271T	TL-271T	2016-09-19
10841983102711	BluPRO®	TL-271T3	TL-271T3	2016-09-19

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