Identity
- Trade Name
- SPEAX Starter Package FDA UDI
- Generic Name
- Voice amplification system FDA UDI
- Device Name
- The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches FDA UDI
- Model / Reference
- FGN-004 FDA UDI
- Description
- The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches FDA UDI
Identifiers
- Catalog Number
- FGN004 FDA UDI
- Primary DI / UDI-DI
- B792FGN004 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice amplification system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
SPEAX Starter Package by Ataia Inc. — 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
- Ataia Inc.
Sources (1)
- FDA UDI e91b4d69-b28b-4a2c-959e-3116542d1e9f 37 fields · synced Jun 1, 2026