Identity
- Trade Name
- Provox SolaTone Plus FDA UDI
- Generic Name
- Transcervical artificial larynx FDA UDI
- Device Name
- An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound. FDA UDI
- Model / Reference
- 7438 FDA UDI
- Description
- An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound. FDA UDI
Identifiers
- Catalog Number
- 7438 FDA UDI
- Primary DI / UDI-DI
- 07331791015823 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
Yes
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
Provox SolaTone Plus by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcervical artificial larynx.
- SolaTone® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- Liberty® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone EMOTE® Electrolarynx — GRIFFIN LABORATORIES · Class I
- SolaTone Plus™ Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone Plus® Electrolarynx — GRIFFIN LABORATORIES · Class I
- TruTone® Electrolarynx — GRIFFIN LABORATORIES · Class I
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
- Atos Medical Inc.
Sources (1)
- FDA UDI 211e798d-c119-42cf-a765-ade00f8e7cef 36 fields · synced May 30, 2026