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

Lithotriptor, Electro-Hydraulic (FFK) (7) Insufflator, Laparoscopic (HIF) (3)

Premarket Exempt

No Yes

Clear

Lithotripsy Probe 1.9FR 250cm French - 00817183020516 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

Autolith Touch - 00817183020523 Catalog Number :

Device Description : Lithotripter, Biliary, BSC, Refurbished

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith Touch - 00817183020530 Catalog Number :

Device Description : Lithotripter, Biliary, BSC, Demo

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith Touch - 00817183020547 Catalog Number :

Device Description : Lithotripter, Biliary, BSC, Loaner

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith Touch - 00817183020554 Catalog Number :

Device Description : Lithotripter, Biliary, BSC, Hospital Owned

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith Touch - 00817183020561 Catalog Number :

Device Description : Lithotripter, Biliary, BSC, Zero Cost Refurbished

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm French - 00817183020578 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

In-Line Gas Warmer - 00817183020592 Catalog Number : 7209944

Device Description : In-Line gas warmer is for use with laparoscopic insufflators

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

TAP - 00817183020608 Catalog Number : 72-00153-0

Device Description : Insufflation Tubing, True Abdominal Pressure Sensing

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Suction Tubing Set - 00817183020622 Catalog Number :

Device Description : Suction Tubing Set with Filter

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

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