Identity
- Trade Name
- Phonak Brand FDA UDI
- Generic Name
- Attention assistive training device FDA UDI
- Device Name
- Roger Focus II (alpine white) FDA UDI
- Model / Reference
- 056-3006-T7 FDA UDI
- Description
- Roger Focus II (alpine white) FDA UDI
Identifiers
- Catalog Number
- 056-3006-T7 FDA UDI
- Primary DI / UDI-DI
- 07613389275537 FDA UDI
- FDA Product Code
- LZI FDA UDI
- GMDN Term
- Attention assistive training device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3320 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: Attention assistive training device
Phonak Brand by Sonova AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sonova AG
Sources (1)
- FDA UDI d2ccb58f-cfed-4bc7-9409-e6b38f241fe2 35 fields · synced Jun 8, 2026