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Neuro Cochlear Implant System

FDA UDI

Class I (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 screwdriver handle FDA UDI
Model / Reference
M80387 FDA UDI
Description
Neuro Zti screwdriver handle FDA UDI

Identifiers

Primary DI / UDI-DI
03663227803877 FDA UDI
PMA Number
P200021 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Cochlear implant system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cochlear implant system

Neuro Cochlear Implant System by Neurelec — Class I — 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 ae4d6887-ec26-4c23-bd9e-2a7c6e484d5e 35 fields · synced May 29, 2026