AXONICS MODULATION TECHNOLOGIES, INC.

Address:26 Technology Dr.,Irvine,CA,92618,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

Stimulator, Electrical, Implantable, For Incontinence (EZW) (10)

Premarket Exempt

Clear

Axonics - 10810005340158 Catalog Number : 2201

Device Description : Tined Lead

Device Class : 3

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 1

Axonics - 10810005340189 Catalog Number : 9001-S

Device Description : Foramen Needle - Short

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 6

Axonics - 10810005340196 Catalog Number : 9001-L

Device Description : Foramen Needle - Long

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 6

Axonics - 10810005340219 Catalog Number : 9003

Device Description : Stimulation Ground Cables

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 6

Axonics - 10810005340226 Catalog Number : 9004

Device Description : Torque Wrench

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 10

Axonics - 10810005340233 Catalog Number : 9005

Device Description : Carrier

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 9

Axonics - 10810005340240 Catalog Number : 9006

Device Description : Needle Test Stim. Cable

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 6

Axonics - 10810005340257 Catalog Number : 9007

Device Description : Tined Lead Test Stim. Cable

Device Class :

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 6

Axonics - 10810005340264 Catalog Number : 9008-R

Device Description : Charging Belt - Regular

Device Class : 3

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 1

Axonics - 10810005340271 Catalog Number : 9008-E

Device Description : Charging Belt - Extended

Device Class : 3

Duns Number: 079562449

Premarket Exempt : No

Product Code : EZW

Prescription Use : Yes

Device Count : 1

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