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) (7) Instrument, Manual, Surgical, General Use (MDM) (1) Orthopedic Manual Surgical Instrument (LXH) (1) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

Clear

Neuro Cochlear Implant System - 03663227003864 Catalog Number :

Device Description : PACKING SET, CHARGEUR

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227003949 Catalog Number :

Device Description : SAFETY LINE, CI

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227003956 Catalog Number :

Device Description : TAMPER, NEURO2 TOOL

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227004007 Catalog Number :

Device Description : Programming Device, Right Wired

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227004014 Catalog Number :

Device Description : Programming Device, Left Wired

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227801736 Catalog Number :

Device Description : Neuro Zti screwdriver

Device Class : 1

Duns Number: 285420530

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227801743 Catalog Number :

Device Description : Neuro Zti Fixation Screws

Device Class : 2

Duns Number: 285420530

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227801750 Catalog Number :

Device Description : Insertion forceps

Device Class : 1

Duns Number: 285420530

Premarket Exempt : No

Product Code : MDM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227801774 Catalog Number :

Device Description : Neuro Zti Magnet Extractor

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

Neuro Cochlear Implant System - 03663227801781 Catalog Number :

Device Description : Neuro Zti Magnet

Device Class : 3

Duns Number: 285420530

Premarket Exempt : No

Product Code : MCM

Prescription Use : No

Device Count : 1

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