StimSite AM-VY1 Adapter

GUDID 00817183020820

StimSite Voyant Adapter

NORTHGATE TECHNOLOGIES INC.

Nerve-locating system
Primary Device ID00817183020820
NIH Device Record Key6d358df3-40f0-4d27-bef5-4beac4269073
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimSite AM-VY1 Adapter
Version Model NumberAM-VY1
Company DUNS627969264
Company NameNORTHGATE TECHNOLOGIES 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 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
GS100817183020820 [Primary]

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 Date2024-07-18
Device Publish Date2024-07-10

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

00817183020820 - StimSite AM-VY1 Adapter2024-07-18StimSite Voyant Adapter
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 Card2023-11-29 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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