Identity
- Trade Name
- Mouth-Aid FDA UDI
- Generic Name
- General oral wound dressing, non-animal-derived FDA UDI
- Device Name
- A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers. FDA UDI
- Model / Reference
- 850035489031 FDA UDI
- Description
- A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers. FDA UDI
Identifiers
- Catalog Number
- ORN0005-01 FDA UDI
- Primary DI / UDI-DI
- 00850035489031 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- General oral wound dressing, non-animal-derived FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General oral wound dressing, non-animal-derived
Mouth-Aid by Orthonu, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, non-animal-derived.
- Surgi-Stop — Terlain Enterprises, Inc. · U
- Canker-X Mouth Sore Spray — ALLIANCE PHARMA INC. · U
- Reso-Pac Hydrophilic Periodontal Dressing — Hager Worldwide, Inc. · Class II
- Orapeutic — FORWARD SCIENCE TECHNOLOGIES LLC · U
- BioStom — FORWARD SCIENCE TECHNOLOGIES LLC · U
- Canker-X Rincinol Mouth Sore Rinse — ALLIANCE PHARMA INC. · U
- BioStom — FORWARD SCIENCE TECHNOLOGIES LLC · U
- Canker-X Mouth Sore Gel — ALLIANCE PHARMA INC. · U
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
- Orthonu, Llc
Sources (1)
- FDA UDI bd02cb6d-e5d5-4e9e-90d3-4e7b3ff6fab7 34 fields · synced May 30, 2026