AVAZZIA INC

Address:13140 Coit Rd Ste 515,DALLAS,TX,75240,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

Binder, Medical, Therapeutic (MDR) (4) Electrode, Cutaneous (GXY) (2) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2)

Premarket Exempt

No Yes

Clear

Avazzia - 00851530007218 Catalog Number : AA-CC

Device Description : Conductive Clips

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : No

Device Count : 1

Avazzia - 00851530007225 Catalog Number : AA-US

Device Description : Uro Probe, Slim

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

Avazzia - 00851530007232 Catalog Number : AA-UR

Device Description : Uro Probe, Regular

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

Avazzia - 00851530007256 Catalog Number : A4-EN-K

Device Description : FirstTX convenience kit includes FirstTX device, lead wire, conductive pads, and FirstTX convenience kit includes FirstTX device, lead wire, conductive pads, and zipper pouch.

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Avazzia - 00851530007287 Catalog Number : AA-CP-Face

Device Description : Conductive Face Mask

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Avazzia - 00851530007294 Catalog Number : AA-CP-Eye

Device Description : Conductive Eye Mask

Device Class : 2

Duns Number: 603638607

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Avazzia - 00851530007300 Catalog Number : AA-CG-Glove

Device Description : Conductive Glove

Device Class : 1

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : MDR

Prescription Use : No

Device Count : 1

Avazzia - 00851530007317 Catalog Number : AA-CG-Sock

Device Description : Conductive Sock

Device Class : 1

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : MDR

Prescription Use : No

Device Count : 1

Avazzia - 00851530007324 Catalog Number : AA-CG-Arm

Device Description : Conductive Arm Sleeve

Device Class : 1

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : MDR

Prescription Use : No

Device Count : 1

Avazzia - 00851530007331 Catalog Number : AA-CG-Leg

Device Description : Conductive Leg Sleeve

Device Class : 1

Duns Number: 603638607

Premarket Exempt : Yes

Product Code : MDR

Prescription Use : No

Device Count : 1

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