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) (10)

Premarket Exempt

No Yes

Clear

TRACE 1 - 10853512006346 Catalog Number : 3010

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006353 Catalog Number : 5533-3

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006360 Catalog Number : 5533-5

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006377 Catalog Number : 5539-5

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006384 Catalog Number : 5550

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006391 Catalog Number : 5559

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006407 Catalog Number : 0915

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 100

TRACE 1 - 10853512006414 Catalog Number : 5560

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006421 Catalog Number : 5500

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

TRACE 1 - 10853512006438 Catalog Number : 2010

Device Description : ECG Electrodes

Device Class :

Duns Number: 073648341

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

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