Nucleus

FDA UDI

Class III (US FDA UDI)

by Cochlear

Identity

Trade Name: Nucleus FDA UDI
Generic Name: Earphone, insert FDA UDI
Device Name: Cochlear EAC200 Series Power Speaker Unit (Size 2, Left) FDA UDI
Model / Reference: Z319071 FDA UDI
Description: Cochlear EAC200 Series Power Speaker Unit (Size 2, Left) FDA UDI

Identifiers

Catalog Number: Z319071 FDA UDI
Primary DI / UDI-DI: 09321502024068 FDA UDI
PMA Number: P130016 FDA UDI
FDA Product Code: PGQ FDA UDI
GMDN Term: Earphone, insert FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Earphone, insert

Nucleus by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Earphone, insert.

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NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
E-A-RTONE™ — 3M COMPANY · Class II
E-A-RTONE™ — 3M COMPANY · Class II
Etymotic — ETYMOTIC RESEARCH, INC. · Class II
ER3C Insert Earphones for Solo — Intelligent Hearing Systems Corp. · Class II

Cleared under the same submission

P130016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Cochlear

Sources (1)

FDA UDI 456fcc91-2d25-46c6-8480-c2d8404e35df 37 fields · synced May 30, 2026