NATUS MANUFACTURING LIMITED

Address:IDA BUSINESS PARK,GORT, Co. Galway,IE

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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, Diagnostic Electromyograph (IKT) (7) Electrode, Needle (GXZ) (2) Cable, Electrode (IKD) (1) Media, Electroconductive (GYB) (1)

Premarket Exempt

No Yes

Clear

Dantec - 00382830041232 Catalog Number :

Device Description : Holder for Dantec™ DCN Disposable Concentric Needle Electrodes

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKD, IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042420 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042437 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042444 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042451 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042468 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Boject - 00382830042475 Catalog Number :

Device Description : Bo-ject Needle

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Grass - 00382830043403 Catalog Number :

Device Description : EC2® GENUINE GRASS ELECTRODE CREAM

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : No

Device Count : 1

Grass - 00382830043601 Catalog Number :

Device Description : F Series. Subdermal Needle. Molded Safelead

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Grass - 00382830043618 Catalog Number :

Device Description : F Series. Subdermal Needle. Molded Safelead

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

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