Neuromaster G1 DC-200BA

GUDID 00841983100215

MAIN UNIT, MEE-2000, G1

NIHON KOHDEN AMERICA, INC.

Neurophysiologic monitoring system
Primary Device ID00841983100215
NIH Device Record Key6f798fd0-cf6b-4983-8ecd-b6b535577768
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuromaster G1
Version Model NumberDC-200B
Catalog NumberDC-200BA
Company DUNS021063219
Company NameNIHON KOHDEN AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841983100215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

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