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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 Solana microM (beige) FDA UDI
Model / Reference
050-0451-01 FDA UDI
Description
Phonak Solana microM (beige) FDA UDI

Identifiers

Catalog Number
050-0451-01 FDA UDI
Primary DI / UDI-DI
07612847885059 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

A comprehensive 2-3 paragraph SEO description written in clear, natural language. The Phonak Solana MicroM is a battery-powered acoustic device designed to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, amplifier, and speaker contained in a case worn behind-the-ear (BTE).

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phonak, Inc.

Sources (1)

  • FDA UDI 9f0e5c30-b525-4115-98c4-600b98233e25 35 fields · synced Jul 20, 2026