NORTHGATE TECHNOLOGIES INC.

Address:1591 Scottsdale Court,Elgin,IL,60123,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Insufflator, Laparoscopic (HIF) (8) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

Nebulae Smoke Evacuation Tubing Set - 00817183020639 Catalog Number :

Device Description : This tubing set is used to evacuate surgical smoke using a wall vacuum source.

Device Class : 2

Duns Number: 627969264

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Adapter for Hoses - 00817183020646 Catalog Number : 72-00328-0

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Connector, Barbed High Flow, Insufflation - 00817183020653 Catalog Number : 72-00147-0

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Smith & Nephew Insufflator 500 - 00817183020677 Catalog Number : 72-00259-0

Device Description : Insufflator, Laparoscopic, 50LPM

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

N/A - 00817183020707 Catalog Number : 72-00160-0

Device Description : Insufflation Tubing, General Use CPC

Device Class :

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

N/A - 00817183020714 Catalog Number : 72-00273-0

Device Description : CO2 Shuttle Valve System, Insufflation

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

N/A - 00817183020721 Catalog Number : 72-00166-0

Device Description : CO2 Hose and DISS, Insufflation

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

N/A - 00817183020738 Catalog Number : 72-00146-0

Device Description : CO2 Hose and Yoke, Insufflation

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Smith & Nephew Insufflator 500 - 00817183020745 Catalog Number : 72-00259-0S

Device Description : Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

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