NEURELEC

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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

Implant, Cochlear (MCM) (10)

Premarket Exempt

Clear

Neuro Cochlear Implant System - 03663227001815 Catalog Number :

Device Description : PACKING SET, NEURO2 ZTI EXCHANGE BOX C092

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001822 Catalog Number :

Device Description : PACKING SET, NEURO2 ZTI EXCHANGE BOX C093

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001839 Catalog Number :

Device Description : PACKING SET, NEURO2 ZTI EXCHANGE BOX C094

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001846 Catalog Number :

Device Description : PACKING SET, NEURO2 ZTI EXCHANGE BOX C098

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001952 Catalog Number :

Device Description : CI-Link exchange

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001969 Catalog Number :

Device Description : CI-LINK FITTING ROOM KIT

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001976 Catalog Number :

Device Description : CI-LINK OPERATING ROOM KIT (ZTI)

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227002003 Catalog Number :

Device Description : Neuro processor indicator

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227002126 Catalog Number :

Device Description : EAR PLUG, RETENTION KIT NEURO2

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227002140 Catalog Number :

Device Description : CLIP, NEURO2

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

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