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Neuro Cochlear Implant System

FDA UDI

Class II (US FDA UDI)

by Neurelec

Identity

Trade Name
Neuro Cochlear Implant System FDA UDI
Generic Name
Cochlear implant system FDA UDI
Device Name
Neuro Zti Fixation Screws FDA UDI
Model / Reference
M80174 FDA UDI
Description
Neuro Zti Fixation Screws FDA UDI

Identifiers

Primary DI / UDI-DI
03663227801743 FDA UDI
PMA Number
P200021 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Cochlear implant system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cochlear implant system

Neuro Cochlear Implant System by Neurelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cochlear implant system.

Cleared under the same submission

P200021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurelec

Sources (1)

  • FDA UDI 82ccf7db-32cf-49fe-a50e-e8e75696d8c5 35 fields · synced May 30, 2026