Identity
- Trade Name
- G16 FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- G16 Speech Generating device FDA UDI
- Model / Reference
- GP16A-G16 FDA UDI
- Description
- G16 Speech Generating device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011903963 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Voice synthesizer/digitizer
G16 by Smartbox Assistive Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Smartbox Assistive Technology Inc
Sources (1)
- FDA UDI b58d689c-2bb8-4e5c-83f1-f7874678a85d 33 fields · synced Jun 1, 2026