Identity
- Trade Name
- MuGard FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle. FDA UDI
- Model / Reference
- Mucoadhesive Oral Wound Rinse FDA UDI
- Description
- MuGard Mucoadhesive Oral Wound Rinse (MuGard) is a non-sterile slightly viscous liquid consisting of film-forming polymers, humectant and dispersion aids, preservatives, sweeteners/flavors and pH modifiers, namely: carbomer homopolymer A, polysorbate 60, glycerin, benzyl alcohol, citric acid, sodium saccharin, potassium hydroxide, and phosphoric acid. The rinse solution is supplied in a flat, white, opaque, eight fluid ounce, high-density polyethylene (HDPE) bottle. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013569907 FDA UDI
- 510(k) Number
- K062795 FDA UDI
- FDA Product Code
- OLR FDA UDIMGQ FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- U 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobialGeneral oral wound dressing, non-animal-derived
MuGard by Soleva Pharma Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General oral wound dressing, non-animal-derived.
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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
- Soleva Pharma Llc
Sources (1)
- FDA UDI a61a3b7a-32f7-468e-a1b0-15f390e54ae5 37 fields · synced May 31, 2026