Insufflation Tubing, Gen Use CPC

GUDID 10817183020322

Insufflation Tubing for use with Laparoscopic Insufflators

NORTHGATE TECHNOLOGIES INC.

Endoscopic insufflation tubing set, single-use
Primary Device ID10817183020322
NIH Device Record Key0bd769c7-b6d3-4d49-a6ad-ceeee04aa447
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsufflation Tubing, Gen Use CPC
Version Model Number7-510-28
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020325 [Primary]
GS110817183020322 [Package]
Contains: 00817183020325
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

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