Identity
- Trade Name
- Saltillo FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- NovaChat 8.4 Set of multiple Keyguards FDA UDI
- Model / Reference
- 19254 FDA UDI
- Description
- NovaChat 8.4 Set of multiple Keyguards FDA UDI
Identifiers
- Catalog Number
- NC8.4-KIT FDA UDI
- Primary DI / UDI-DI
- 00816486021169 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Voice synthesizer/digitizer
Saltillo by Prentke Romich Company — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (2)
- FDA UDI 54413db8-6793-4fa5-94f1-bad569b2d4e5 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026