Identity
- Trade Name
- MICROSOFT FDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Model / Reference
- S31-00001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- G549S31000010 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Assistive speech generator 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Assistive speech generator
Microsoft by RCS Management Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive speech generator.
- QuickTalker Freestyle — AbleNet Inc. · Class II
- Eyegaze — Lc Technologies, Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- QuickTalker Freestyle Mini — AbleNet Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- QuickTalker Freestyle Mini — AbleNet Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RCS Management Corporation
Sources (1)
- FDA UDI 7ebf4169-419c-45a7-a917-d3e52c4612e7 32 fields · synced Jun 1, 2026