Identity
- Trade Name
- Renú Voice FDA UDI
- Generic Name
- Injectable vocal cord medialization implant, synthetic FDA UDI
- Device Name
- Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. FDA UDI
- Model / Reference
- 08-015-04-V04 FDA UDI
- Description
- Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. FDA UDI
Identifiers
- Catalog Number
- 08-015-04-V04 FDA UDI
- Primary DI / UDI-DI
- 00856509002294 FDA UDI
- FDA Product Code
- MIX FDA UDI
- GMDN Term
- Injectable vocal cord medialization implant, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1.5 Milliliter FDA UDI
Category: Injectable vocal cord medialization implant, synthetic
Renú Voice by Cytophil, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Injectable vocal cord medialization implant, synthetic.
- SilkVoice — Sofregen Medical, Inc. · Class II
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- Prolaryn Gel Injectable Implant — Merz North America, Inc. · Class II
- SilkVoice — Sofregen Medical, Inc. · Class II
- SilkVoice — Sofregen Medical, Inc. · Class II
- SilkVoice — Sofregen Medical, Inc. · Class II
- SilkVoice — Sofregen Medical, Inc. · Class II
- Prolaryn Plus Injectable Implant — Merz North America, 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 |
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Manufacturer
- Manufacturer
- Cytophil, Inc
Sources (1)
- FDA UDI 5c3a40ba-ceb8-4747-a030-d72bda9e19f7 36 fields · synced Jun 1, 2026