Identity
- Trade Name
- Reso-Pac Hydrophilic Periodontal Dressing FDA UDI
- Generic Name
- General oral wound dressing, non-animal-derived FDA UDI
- Model / Reference
- 155018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D2481550180 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- General oral wound dressing, non-animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
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
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
Reso-Pac Hydrophilic Periodontal Dressing by Hager Worldwide, Inc. — Class II — 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
- 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
- Comfort Tape — ORTHONU, LLC · Class I
Cleared under the same submission
K050648 also covers:
K050658 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hager Worldwide, Inc.
Sources (1)
- FDA UDI 5a6cff4c-fd99-4a38-a9e6-40b90f421c3e 35 fields · synced Jun 9, 2026