Nexstim Cooled Coil NX76810

GUDID 06430063200095

Nexstim Cooled Coil

NEXSTIM, INC.

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Primary Device ID06430063200095
NIH Device Record Keydd0e0584-875c-4690-82a6-d7ef9b6a9e7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexstim Cooled Coil
Version Model NumberNX75048
Catalog NumberNX76810
Company DUNS010845069
Company NameNEXSTIM, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com
Phone+35892727170
Emailinfo@nexstim.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106430063200095 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

Devices Manufactured by NEXSTIM, INC.

06430063200002 - Nexstim NBS software2018-07-06 NBS main software
06430063200026 - NexSpeech main software2018-07-06 NexSpeech Main Software
06430063200033 - NexSpeech analyzer software2018-07-06 NexSpeech Analyzer Software
06430063200057 - Nexstim NBS System2018-07-06 Nexstim NBS System
06430063200064 - Nexstim NBS software GER2018-07-06 Nexstim NBS German Main Software
06430063200088 - Nexstim Focal Coil2018-07-06 Nexstim Focal Coil
06430063200095 - Nexstim Cooled Coil2018-07-06Nexstim Cooled Coil
06430063200095 - Nexstim Cooled Coil2018-07-06 Nexstim Cooled Coil
06430063200118 - Nexstim NBS Orange Head Tracker2018-07-06 Nexstim NBS Orange Head Tracker (box of 20) New part list nr NX103354

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