Identity
- Trade Name
- TruTone EMOTE® Electrolarynx FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Model / Reference
- K1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813124010141 FDA UDI
- FDA Product Code
- ESE FDA UDI
- GMDN Term
- Transcervical artificial larynx FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3375 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
Category: Transcervical artificial larynx
TruTone EMOTE® Electrolarynx by Griffin Laboratories — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Griffin Laboratories
Sources (1)
- FDA UDI 452050d3-7062-4325-a5a9-c6d42c31242b 32 fields · synced May 29, 2026