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Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant

FDA UDI

Class III (US FDA UDI)

by Cochlear

Identity

Trade Name
Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant FDA UDI
Generic Name
Auditory brainstem implant system electrode array assembly FDA UDI
Device Name
N/A FDA UDI
Model / Reference
Z246604 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
Z246604 FDA UDI
Primary DI / UDI-DI
09321502020404 FDA UDI
PMA Number
P000015 FDA UDI
FDA Product Code
MHE FDA UDI
GMDN Term
Auditory brainstem implant system electrode array assembly FDA UDI

Classification

Device Class
Class III 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Auditory brainstem implant system electrode array assembly

Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Auditory brainstem implant system electrode array assembly.

Cleared under the same submission

P000015 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear

Sources (1)

  • FDA UDI fceea31c-a637-4595-9658-01b20dc430b7 37 fields · synced May 30, 2026