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 - 03663227000894 Catalog Number :

Device Description : CI-Link Unit Programming System

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001464 Catalog Number :

Device Description : SOUND PROCESSOR, NEURO2 ZTI C090

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001471 Catalog Number :

Device Description : SOUND PROCESSOR, NEURO2 ZTI C063

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001532 Catalog Number :

Device Description : Genie Medical CI Fitting Software

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001549 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C044

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001556 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C057

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001563 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C058

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001570 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C063

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001587 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C090

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

Neuro Cochlear Implant System - 03663227001594 Catalog Number :

Device Description : SET, SOUND PROCESSOR NEURO2 ZTI C091

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : Yes

Device Count : 1

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