StimSite Activation Card

GUDID 00817183020776

Activation Card, StimSite, Single

NORTHGATE TECHNOLOGIES INC.

Nerve-locating system
Primary Device ID00817183020776
NIH Device Record Keyf2ba28a9-6fb0-4bac-b9e3-1c77502dd013
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimSite Activation Card
Version Model NumberAM-2101
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 Batchtrue
Serial Numberfalse
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
GS100817183020776 [Primary]
GS100860002926919 [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 Date2023-11-29
Device Publish Date2023-11-21

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

00817183020820 - StimSite AM-VY1 Adapter2024-07-18 StimSite Voyant Adapter
10817183020810 - PUREPNEUMO Tubing Set2024-07-17 Paired Insufflation and TAP Tubing
00817183020769 - StimSite Signal Box2024-05-07
00817183020776 - StimSite Activation Card2023-11-29Activation Card, StimSite, Single
00817183020776 - StimSite Activation Card2023-11-29 Activation Card, StimSite, Single
00817183020660 - NEBULAE SRS Tubing Set2023-02-22
00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump2023-02-22
00817183020745 - Smith & Nephew Insufflator 5002021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM
10817183020605 - TAP2021-01-13 Insufflation Tubing, True Abdominal Pressure Sensing

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