MEDIMAX TECH INC.

Address:2805 E ANA ST,Compton,CA,90221,US

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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

Electrode, Needle (GXZ) (10) Electrode, Needle, Diagnostic Electromyograph (IKT) (10)

Premarket Exempt

No Yes

Clear

MediMax Tech - 00817325020008 Catalog Number :

Device Description : BC2530 Needle Electrodes - Concentric Needle, Non-Wired, 25mm Length, 0.30mm(30G BC2530 Needle Electrodes - Concentric Needle, Non-Wired, 25mm Length, 0.30mm(30G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : IKT, GXZ

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020015 Catalog Number :

Device Description : BC2530P Needle Electrodes - Concentric Needle, Prewired, 25mm Length, 0.30mm(30G BC2530P Needle Electrodes - Concentric Needle, Prewired, 25mm Length, 0.30mm(30G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : GXZ, IKT

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020022 Catalog Number :

Device Description : BC2526 Needle Electrodes - Concentric Needle, Non-Wired, 25mm Length, 0.45mm(26G BC2526 Needle Electrodes - Concentric Needle, Non-Wired, 25mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : IKT, GXZ

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020039 Catalog Number :

Device Description : BC2526P Needle Electrodes - Concentric Needle, Prewired, 25mm Length, 0.45mm(26G BC2526P Needle Electrodes - Concentric Needle, Prewired, 25mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : GXZ, IKT

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020046 Catalog Number :

Device Description : BC3028 Needle Electrodes - Concentric Needle, Non-Wired, 30mm Length, 0.36mm(28G BC3028 Needle Electrodes - Concentric Needle, Non-Wired, 30mm Length, 0.36mm(28G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : GXZ, IKT

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020053 Catalog Number :

Device Description : BC3028P Needle Electrodes - Concentric Needle, Prewired, 30mm Length, 0.36mm(28G BC3028P Needle Electrodes - Concentric Needle, Prewired, 30mm Length, 0.36mm(28G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : IKT, GXZ

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020060 Catalog Number :

Device Description : BC3826 Needle Electrodes - Concentric Needle, Non-Wired, 38mm Length, 0.45mm(26G BC3826 Needle Electrodes - Concentric Needle, Non-Wired, 38mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : GXZ, IKT

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020077 Catalog Number :

Device Description : BC3826P Needle Electrodes - Concentric Needle, Prewired, 38mm Length, 0.45mm(26G BC3826P Needle Electrodes - Concentric Needle, Prewired, 38mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : IKT, GXZ

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020084 Catalog Number :

Device Description : BC5026 Needle Electrodes - Concentric Needle, Non-Wired, 50mm Length, 0.45mm(26G BC5026 Needle Electrodes - Concentric Needle, Non-Wired, 50mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : GXZ, IKT

Prescription Use : Yes

Device Count : 1

MediMax Tech - 00817325020091 Catalog Number :

Device Description : BC5026P Needle Electrodes - Concentric Needle, Prewired, 50mm Length, 0.45mm(26G BC5026P Needle Electrodes - Concentric Needle, Prewired, 50mm Length, 0.45mm(26G) Diameter.

Device Class : 2

Duns Number: 927071162

Premarket Exempt : No

Product Code : IKT, GXZ

Prescription Use : Yes

Device Count : 1

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