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

Electrode, Electrocardiograph (DRX) (3) Electrode, electrocardiograph (DRX) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

NikoSurg - 10853512006643 Catalog Number : 4800

Device Description : Neutral Electrodes

Device Class : 2

Duns Number: 073648341

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

TRACE 1 - 10853512006650 Catalog Number : 0916

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 50

NIKOPrep - 10853512006711 Catalog Number : 2121

Device Description : Strips for Skin Preparation

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 500

Nikotab - 10853512006759 Catalog Number : 1015

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 100

NIKOPrep - 10853512006766 Catalog Number : 2121-5

Device Description : Strips for Skin Preparation (1 card of 5 pieces)

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 5

NIKOPrep - 10853512006773 Catalog Number : 2121/E 240

Device Description : Strips for Skin Preparation (Individual Pieces)

Device Class : 2

Duns Number: 073648341

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 500

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