NEBULAE SRS Tubing Set

GUDID 00817183020660

NORTHGATE TECHNOLOGIES INC.

Laparoscopic plume filter
Primary Device ID00817183020660
NIH Device Record Key9fd3c729-90b1-4d12-8e1f-87616423251d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEBULAE SRS Tubing Set
Version Model Number7-510-57
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020660 [Primary]
GS110817183020667 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYDApparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

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00817183020769 - StimSite Signal Box2024-05-07
00817183020776 - StimSite Activation Card2023-11-29 Activation Card, StimSite, Single
00817183020660 - NEBULAE SRS Tubing Set2023-02-22
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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