EMPI, 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) (10)

Premarket Exempt

No Yes

Clear

Iontophoresis Dupel Blue Small 1.5mL - 00888912151337 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Dupel Blue Butterfly 2.0 mL - 00888912151344 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Dupel Blue Medium - Standard 2.5 mL - 00888912151351 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iontophoresis Dupel Blue Large 4.0 mL - 00888912151368 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

KIT, DUPEL II, w/SAFETY SOCKET - 00888912151375 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Kit Dupel II International complete w/safety socket - 00888912151382 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Dupel Kit Iontophoresis Device - 00888912151399 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Companion 80 1.1 cc electrode, Box of 6 - 00888912151405 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iogel Medium 2.5 cc electrode, Box of 12 - 00888912151412 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Iogel Large 3.5 cc electrode, Box of 12 - 00888912151429 Catalog Number :

Device Class : 2

Duns Number: 039375910

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

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