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, Cutaneous (GXY) (5) Electrode, Needle (GXZ) (5)

Premarket Exempt

Clear

The Electrode Store - 00816022020601 Catalog Number : DSC-SAF

Device Description : Detachable Needle Electrode Cable, Shielded 24" lead w/two 1.5mm sockets

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020687 Catalog Number : GK-D50SAF

Device Description : Disposable Stim Needle Electrodes, 50mm(2")x 26 Ga Coated (5 Red, 5 Black)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020694 Catalog Number : GK-D75SAF

Device Description : Disposable Stim Needle Electrodes, 75mm(3")x 24 Ga Coated (5 Red, 5 Black)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020786 Catalog Number : SDN1248

Device Description : Intraoperative Needle Electrodes, Subdermal 12mm X 29 ga Steel, 48" wires

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020793 Catalog Number : SDN1280

Device Description : Intraop. Needle Electrodes, Subdermal 12mm X 29 ga Steel, 80" wires (10pr)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020809 Catalog Number : SDN1248B

Device Description : Intraoperative Needle Electrodes, Subdermal 12mmX 29 ga, 48" Braided Wires

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020861 Catalog Number : 1023

Device Description : Disposable Surface Electrode w/24" Colored Leads (3/strip x 10 strips)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020878 Catalog Number : 1023(2)

Device Description : Disposable Surface Electrode w/24" Colored Leads (3/strip x 2 strips)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020885 Catalog Number : 1025

Device Description : Disposable Surface Electrode w/24" Colored Leads (4/strip x 10 strips)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020892 Catalog Number : 1025(2)

Device Description : Disposable Surface Electrode w/24" Colored Leads (4/strip x 2 strips)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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