NORTHGATE TECHNOLOGIES INC.

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

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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

Lithotriptor, Electro-Hydraulic (FFK) (6) Insufflator, Laparoscopic (HIF) (4)

Premarket Exempt

No Yes

Clear

Extender Cable, Autolith - 00817183020127 Catalog Number :

Device Description : Extender cable for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 250cm - 00817183020134 Catalog Number :

Device Description : 1.9FR 250cm Lithotripsy Probe for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm - 00817183020141 Catalog Number :

Device Description : 1.9FR 375cm Lithotripsy Probe for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm DS - 00817183020158 Catalog Number :

Device Description : 1.9FR 375cm DS Lithotripsy Probe for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 120cm - 00817183020165 Catalog Number :

Device Description : 1.9FR 120cm Lithotripsy Probe for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 9FR 54cm - 00817183020172 Catalog Number :

Device Description : 9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Nebulae I - 00817183020189 Catalog Number :

Device Description : Laparoscopic Insufflator 50LPM

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

CO2 Hose and Yoke - 00817183020196 Catalog Number :

Device Description : CO2 Hose and Yoke for use with Laparoscopic insufflators

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

CO2 Hose and Yoke Shuttle Valve System - 00817183020202 Catalog Number :

Device Description : CO2 Hose and Yoke Shuttle Valve System is for use with Laparoscopic insufflators CO2 Hose and Yoke Shuttle Valve System is for use with Laparoscopic insufflators for hook up to two CO2 tanks.

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Insufflation Tubing, Laparoscopic - 00817183020226 Catalog Number :

Device Description : Insufflation general use tubing set for use with the Nebulae I laparoscopic insufflator

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

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