Identity
- Trade Name
- Lavior FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Diabetic hydrogel for wounds. LAVIOR Diabetic Hydrogel Wound Dressing is a groundbreaking, clinically proven wound care product. By creating a moist wound environment, LAVIOR Diabetic Hydrogel assists in autolytic debridement of wounds covered with necrotic tissues. Through its healing properties, LAVIOR Diabetic Hydrogel works to promote healing and healthier skin. It is indicated for cuts, scrapes, abrasions, and diabetic skin ulcers. FDA UDI
- Model / Reference
- DWC10US1 FDA UDI
- Description
- Diabetic hydrogel for wounds. LAVIOR Diabetic Hydrogel Wound Dressing is a groundbreaking, clinically proven wound care product. By creating a moist wound environment, LAVIOR Diabetic Hydrogel assists in autolytic debridement of wounds covered with necrotic tissues. Through its healing properties, LAVIOR Diabetic Hydrogel works to promote healing and healthier skin. It is indicated for cuts, scrapes, abrasions, and diabetic skin ulcers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010195703 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
Lavior by Lavior Pharma Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
- Orasoothe Oral Coating Rinse 4oz – Hygiene — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- Microcyn Skin & Wound HydroGel — Sonoma Pharmaceuticals, Inc. · U
- MYNX CONTROL — Accessclosure, Inc. · Class III
- HydroTac transparent 10x10cm steril P10 — Paul Hartmann Corp. · Class I
- Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lavior Pharma Inc.
Sources (1)
- FDA UDI 539c7548-fe92-420f-837b-f0adcb323df7 35 fields · synced May 30, 2026