Lavior
GUDID 00860010195734
LAVIOR Hydrogel Wound Dressing helps to enhance wound recovery by providing a moist, wound-healing environment through its unique ability to address multiple wound concerns simultaneously. It promotes healing by introducing a hydrating base to the wound, thereby rehydrating necrotic tissue and aiding in debridement. These mechanisms work together to provide moisture to damaged skin, thus fostering tissue regeneration and preventing scarring.
Lavior Pharma Inc.
Wound hydrogel dressing, non-antimicrobial| Primary Device ID | 00860010195734 |
| NIH Device Record Key | 27d4fd92-b9c4-4b7f-b896-dd58bfe3381d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lavior |
| Version Model Number | NDWC10US1 |
| Company DUNS | 080685327 |
| Company Name | Lavior Pharma Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com | |
| Phone | (305) 627-3680 |
| info@lavior.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860010195734 [Primary] |
FDA Product Code
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-31 |
| Device Publish Date | 2023-10-23 |
On-Brand Devices [Lavior]
| 00860010195703 | Diabetic hydrogel for wounds. LAVIOR Diabetic Hydrogel Wound Dressing is a groundbreaking, clin |
| 00860010195734 | LAVIOR Hydrogel Wound Dressing helps to enhance wound recovery by providing a moist, wound-heali |
Trademark Results [Lavior]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAVIOR 87134822 not registered Live/Pending |
LAVIOR INC 2016-08-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.