Phonak

FDA UDI

Class II (US FDA UDI)

by Phonak, Inc.

Identity

Trade Name: Phonak FDA UDI
Generic Name: Air-conduction hearing aid, behind-the-ear FDA UDI
Device Name: Phonak Sky V70-P (caribbean pirate) FDA UDI
Model / Reference: 050-0332-Q3 FDA UDI
Description: Phonak Sky V70-P (caribbean pirate) FDA UDI

Identifiers

Catalog Number: 050-0332-Q3 FDA UDI
Primary DI / UDI-DI: 07613275390818 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Air-conduction hearing aid, behind-the-ear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3305 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Air-conduction hearing aid, behind-the-ear

Phonak by Phonak, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, behind-the-ear.

Oticon — Oticon A/S · Class II
Amplifon — Sonova AG · Class II
Phonak Naída L30-SP — Sonova AG · Class II
GN ReSound — Gn Hearing A/S · Class II
Miracle-Ear — WS Audiology USA, Inc. · Class II
NUEAR — Starkey Laboratories Inc. · Class II
HHM — Oticon A/S · Class II
Signia — WS Audiology USA, Inc. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Phonak, Inc.

Sources (1)

FDA UDI 0a3a05ac-ec44-4fdb-bfb3-6d8a213ccd7d 35 fields · synced May 31, 2026