Identity
- Trade Name
- Phonak FDA UDI
- Generic Name
- Hearing aid enhanced audio device, teaching-environment FDA UDI
- Device Name
- Roger 11 (02) (ruby) FDA UDI
- Model / Reference
- 052-3183-D02P9 FDA UDI
- Description
- Roger 11 (02) (ruby) FDA UDI
Identifiers
- Catalog Number
- 052-3183-D02P9 FDA UDI
- Primary DI / UDI-DI
- 07612904269501 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Hearing aid enhanced audio device, teaching-environment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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
MR Unsafe FDA UDI
Category: Hearing aid enhanced audio device, teaching-environment
Phonak by Phonak, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid enhanced audio device, teaching-environment.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Phonak — Phonak, Inc. · Class I
- Phonak — Phonak, Inc. · Class I
- Phonak — Phonak, Inc. · Class I
- Phonak — Phonak, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Phonak, Inc.
Sources (1)
- FDA UDI c168443a-e401-4563-8d18-92cf9c1275be 35 fields · synced May 31, 2026