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, Cutaneous (GXY) (6) Electrode, Needle, Diagnostic Electromyograph (IKT) (4)

Premarket Exempt

No Yes

Clear

Grass - 00382830017404 Catalog Number :

Device Description : Genuine GRASS 10mm Gold Cup-Disc Electrodes- Reusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Grass - 00382830017411 Catalog Number :

Device Description : Genuine GRASS 10mm Gold Cup-Disc Electrodes- Reusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Grass - 00382830017428 Catalog Number :

Device Description : Genuine GRASS 10mm Gold Cup-Disc Electrodes- Reusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Grass - 00382830017435 Catalog Number :

Device Description : Genuine GRASS 10mm Gold Cup-Disc Electrodes- Reusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Grass - 00382830017442 Catalog Number :

Device Description : Genuine GRASS 10mm Silver Cup-Disc Electrodes -Resusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Grass - 00382830017459 Catalog Number :

Device Description : Genuine GRASS 10mm Silver Cup-Disc Electrodes -Resusable

Device Class : 2

Duns Number: 896421240

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : No

Device Count : 1

Teca Elite - 00382830017480 Catalog Number :

Device Description : TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Teca Elite - 00382830017497 Catalog Number :

Device Description : TECA ELITE Disposable Concentric Yellow Needle, 25mm, .46(26G) diameter, 25 per Pk

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Teca Elite - 00382830017503 Catalog Number :

Device Description : TECA ELITE Disposable Concentric Green Needle, 37mm,.46(26G) diameter, 25 per Pk

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Teca Elite - 00382830017510 Catalog Number :

Device Description : TECA ELITE Disposable Concentric Blue Needle, 50mm, .46(26G) diameter, 25 per Pk

Device Class : 2

Duns Number: 896421240

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

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