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) (10) Insufflator, Laparoscopic (HIF) (1)

Premarket Exempt

No Yes

Clear

Autolith Touch - 00817183020004 Catalog Number :

Device Description : Lithotripter

Device Class :

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Footswitch - 00817183020011 Catalog Number : 9-001-00

Device Description : Pneumatic footswitch for use with Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Extender Cable, Autolith Touch/Uro-Touch - 00817183020028 Catalog Number :

Device Description : Extender cable for use with Autolith Touch and Autolith Uro-Touch Lithotripters

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Power Cord - 00817183020035 Catalog Number :

Device Description : Hospital Grade Power Cord

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : HIF, FFK

Prescription Use : No

Device Count : 1

Lithotripsy Probe 1.9FR 250cm - 00817183020059 Catalog Number :

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

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 375cm - 00817183020066 Catalog Number :

Device Description : 1.9FR 375cm Lithotripsy Probe for use with Autolith Touch 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 - 00817183020073 Catalog Number :

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

Device Class : 2

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : No

Device Count : 1

Autolith Uro-Touch - 00817183020080 Catalog Number :

Device Description : Lithotripter for Urology Use

Device Class :

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 1.9FR 120cm - 00817183020103 Catalog Number :

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

Device Class :

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Lithotripsy Probe 9FR 54cm - 00817183020110 Catalog Number :

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

Device Class :

Duns Number: 627969264

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

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