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) (8) Insufflator, Laparoscopic (HIF) (1) System, Irrigation, Urological (LJH) (1)

Premarket Exempt

No Yes

Clear

Flo-Assist II - 00817183020363 Catalog Number :

Device Description : Irrigation Tubing Set

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : LJH

Prescription Use : Yes

Device Count : 1

Autolith 115V - 00817183020370 Catalog Number :

Device Description : Lithotripter

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith 100V - 00817183020394 Catalog Number :

Device Description : Lithotripter

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Suction Tubing Set - 00817183020417 Catalog Number :

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm DS - 00817183020448 Catalog Number :

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

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : No

Device Count : 1

Extender Cable, Autolith Touch - 00817183020455 Catalog Number :

Device Description : Extender cable for use with Autolith Touch Lithotripter, BSC

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Power Cord, Autolith Touch, North America - 00817183020462 Catalog Number : 72-00324-0

Device Description : Power cord for use with Autolith Touch Lithotripter, BSC

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Foot Switch, Autolith Touch - 00817183020479 Catalog Number : 72-00323-0

Device Description : Foot switch for use with Autolith Touch Lithotripter, BSC

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Autolith Touch - 00817183020493 Catalog Number : 72-00275-0

Device Description : Lithotripter, Biliary, BSC

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm DS French - 00817183020509 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

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