Identity
- Trade Name
- Orapeutic FDA UDI
- Generic Name
- General oral wound dressing, non-animal-derived FDA UDI
- Device Name
- Orapeutic is an oral hydrogel wound dressing that is applied to wounds / ulcers in the oral cavity for the management of oral pain. The gel is applied in small amounts (typically pea-sized) to cover the wound(s) as needed and dissolves over time. FDA UDI
- Model / Reference
- Orapeutic 5ct FDA UDI
- Description
- Orapeutic is an oral hydrogel wound dressing that is applied to wounds / ulcers in the oral cavity for the management of oral pain. The gel is applied in small amounts (typically pea-sized) to cover the wound(s) as needed and dissolves over time. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370275713050 FDA UDI
- FDA Product Code
- MGQ FDA UDIOLR FDA UDI
- GMDN Term
- General oral wound dressing, non-animal-derived FDA UDI
Classification
- Device Class
- U 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
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
Category: General oral wound dressing, non-animal-derived
Orapeutic by Forward Science Technologies Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, non-animal-derived.
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- Canker-X Rincinol Mouth Sore Rinse — ALLIANCE PHARMA INC. · U
- Canker-X Mouth Sore Gel — ALLIANCE PHARMA INC. · U
- Comfort Tape — ORTHONU, LLC · Class I
- Reso-Pac Hydrophilic Periodontal Dressing — Hager Worldwide, Inc. · Class II
- Mouth-Aid — ORTHONU, LLC · 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 U | Pending data |
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Manufacturer
- Manufacturer
- Forward Science Technologies Llc
Sources (1)
- FDA UDI f93ef7d5-0c31-43cb-af93-fe0461274295 33 fields · synced Jun 8, 2026