NIKOMED USA

NIKOMED USA

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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

Cable, Electrode (IKD) (6) Electrode, electrocardiograph (DRX) (3) Electrosurgical, cutting & coagulation & accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

NIKO-Surg - 00853512006660 Catalog Number : 3405

Device Description : Reusable Grounding Pad Cable 10' with a 6mm plug connector

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NIKO-Surg - 00853512006677 Catalog Number : 3406

Device Description : Reusable Grounding Pad Cable 10' with a 4mm shrouded plug connector

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NIKO-Surg - 00853512006684 Catalog Number : 3407

Device Description : Reusable Grounding Pad Cable 10' with a Valleylab style connector and no center

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NIKO-Surg - 00853512006691 Catalog Number : 3508

Device Description : Reusable Grounding Pad Cable 10' with a Valleylab style connector and center pin

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NIKO-Surg - 00853512006707 Catalog Number : 3509

Device Description : Reusable Grounding Pad Cable 10' with a Boston Scientific style connector, Non-R

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Nikomed ECG Cable - 00853512006745 Catalog Number : 3603

Device Description : 3 Lead Monitor Cable

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NikoSurg - 10853512006223 Catalog Number : 4777

Device Description : Neutral Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

TRACE 1 - 10853512006315 Catalog Number : 5511

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006322 Catalog Number : 2014

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

Nikotab - 10853512006339 Catalog Number : 0215

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 100

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