ACTIVATEK INC.

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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

Device, Iontophoresis, Other Uses (EGJ) (8)

Premarket Exempt

Clear

ActivaPatch IontoGo 4.0 Sample - 00859975005097 Catalog Number : SA89189

Device Description : ActivaPatch IontoGo 4.0 Sample Pack (2)

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 2

ActivaPatch IontoGo 12.0 Sample - 00859975005103 Catalog Number : SA89191

Device Description : ActivaPatch IontoGo 12.0 Sample Pack (2)

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 2

Trivarion Large Sample - 00859975005127 Catalog Number : SA89182B

Device Description : Trivarion Buffered Iontophoretic Delivery Kit- Large Sample Pack (2)

Device Class : 2

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Trivarion Small Sample - 00859975005141 Catalog Number : SA89180B

Device Description : Trivarion Buffered Iontophoretic Delivery Kit- Small, 1.5cc Sample Pack (2)

Device Class : 2

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

ActivaPatch IntelliDose 2.5 Sample - 00859975005158 Catalog Number : SA89188

Device Description : ActivaPatch IntelliDose 2.5 Sample Pack (2)

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 2

ActivaPatch IontoGo 4.0 - 00859975005202 Catalog Number : NC89189

Device Description : ActivaPatch IontoGo 4.0 carton with 6 pouches. 4 hour iontophoresis delivery.

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 6

ActivaPatch - 00859975005219 Catalog Number : NC89188

Device Description : IntelliDose, 2.5 hour iontophoresis delivery

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 6

ActivaPatch IontoGo 12.0 - 00859975005226 Catalog Number : NC89191

Device Description : ActivaPatch IontoGo 12.0 carton with 6 pouches, 12 hour iontophoresis delivery

Device Class :

Duns Number: 790584176

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 6

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