IMPULSE MEDICAL TECHNOLOGIES, 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

Electrode, Needle (GXZ) (10)

Premarket Exempt

Clear

The Electrode Store - 00816022020007 Catalog Number : PRO-25F

Device Description : Protectrode™ Disposable Monopolar EMG Needle Electrodes, 25mm(1") X 29 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020021 Catalog Number : PRO-37SAF

Device Description : Protectrode Disposable Monopolar EMG Needle Electrodes, 37mm(1.5") X 27 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020038 Catalog Number : PRO-25SAF(5)

Device Description : Protectrode™ Disposable Monopolar Needle Electrodes, 1.00" EMG NEEDLE

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020045 Catalog Number : PRO-37SAF(5)

Device Description : Protectrode™ Disposable Monopolar Needle Electrodes, 1.50" EMG NEEDLE

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020052 Catalog Number : PRO-50SAF

Device Description : Protectrode™ Disposable Monopolar EMG Needle Electrodes, 50mm(2") X 26 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020069 Catalog Number : PRO-50SAF(5/PK)

Device Description : Protectrode™ Disposable Monopolar Needle Electrodes, 2.00" EMG NEEDLE

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020076 Catalog Number : DMD-25(PKG/30)

Device Description : Protectrode Disposable Mono. Needle Electrode, NO CABLE, 25mm(1")X28 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020083 Catalog Number : DMD-37(PKG/30)

Device Description : Protectrode Disposable Mono. Needle Electrode, NO CABLE, 37mm(1.5")X27 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020090 Catalog Number : DMD-50(PKG/30)

Device Description : Protectrode Disposable Mono. Needle Electrode, NO CABLE, 50mm(2")X26 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020106 Catalog Number : PRO-S95

Device Description : Protectrode™ Disposable Monopolar EMG Needle Electrode Stand

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

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