Identity
- Trade Name
- Renú Transoral Needle FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use. FDA UDI
- Model / Reference
- 12-000-00-ND1 FDA UDI
- Description
- Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use. FDA UDI
Identifiers
- Catalog Number
- 12-000-00-ND1 FDA UDI
- Primary DI / UDI-DI
- 00856509002669 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose endoscopic needle, single-use
Renú Transoral Needle by Cytophil, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, single-use.
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- Injectra, ScleroTip — Medi-Globe Corporation · Class II
- Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
- Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · 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
- Cytophil, Inc
Sources (1)
- FDA UDI 9c1a5c43-9cb1-41c0-a7ff-73fa892f3417 34 fields · synced May 30, 2026