StimSite Signal Box

GUDID 00817183020769

NORTHGATE TECHNOLOGIES INC.

Nerve-locating system
Primary Device ID00817183020769
NIH Device Record Key1b9d6a8a-e287-4373-ae55-78fff914faa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimSite Signal Box
Version Model NumberAM-101
Company DUNS627969264
Company NameNORTHGATE TECHNOLOGIES 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020769 [Primary]
GS100860002926902 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNStimulator, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-07
Device Publish Date2024-04-29

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

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