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 (GXZ) (4) Cable, Electrode (IKD) (3) Stimulator, Electrical, Evoked Response (GWF) (2) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

No Yes

Clear

Grass - 00382830043625 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 - 00382830043632 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 - 00382830043649 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 - 00382830043656 Catalog Number :

Device Description : F Series. Naso Gold. 15CM Naso. Molded Safelead.

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Keypoint - 00382830047661 Catalog Number : 9013C0142

Device Description : Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (7 Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (79"), 5-pin DIN, 1/pkg

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Keypoint - 00382830047678 Catalog Number : 9013C0023

Device Description : Coaxial cable for DCF/DCN electrode 2m

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Keypoint - 00382830047685 Catalog Number : 9013C0242

Device Description : Reusable Unshielded Cable for EMG and IOM 0.7mm female touchproof, 2.0m (79"), ( Reusable Unshielded Cable for EMG and IOM 0.7mm female touchproof, 2.0m (79"), (1.5mm DIN), 8/pkg

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Keypoint - 00382830047692 Catalog Number : 9013S0402

Device Description : Reusable Hush Shielded Disc Electrode

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830047722 Catalog Number :

Device Description : Extension cable for goggles

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : GWF

Prescription Use : No

Device Count : 1

Keypoint - 00382830047746 Catalog Number : 9013L0241

Device Description : Tremor Sensor - Reusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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