INCEREB LIMITED

Address:6 Charlemont Terrace,Dublin Dun Laoghaire-Rathdown,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) (5)

Premarket Exempt

Clear

neon12 - 05391530950008 Catalog Number :

Device Description : EEG electrode array sized for use with neonatal infants. The array has qty 12 e EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only

Device Class : 2

Duns Number: 985065024

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

neon8 - 05391530950039 Catalog Number :

Device Class : 2

Duns Number: 985065024

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

neon8 - 05391530950077 Catalog Number :

Device Description : EEG electrode array sized for use with neonatal infants. The array has qty 8 el EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This new DI is a new packaging format. The old number was a tray with a peel off lid. This DI is the "Clamshell" in a pouch packaging

Device Class : 2

Duns Number: 985065024

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Neon 12 KIT - 05391530950091 Catalog Number :

Device Description : Kit version of neon12, packaged without electrode paste or skin prep gel

Device Class :

Duns Number: 985065024

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Neon8 KIT - 05391530950107 Catalog Number :

Device Description : Neon8 KIT version, packaged without electrode paste or skin prep gel

Device Class :

Duns Number: 985065024

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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