FDA Registration
Active
🇺🇸 United States
BIOWOUND SOLUTIONS
Reg #: 3034456223
·
FEI: 3034456223
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BIOWOUND SOLUTIONS
- Registration Number
- 3034456223
- FEI Number
- 3034456223
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6823 W Post Rd Ste 102
- City
- Las Vegas
- State
- NV
- ZIP
- 89118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080949
Owner / Operator
- Firm Name
- BioWound Solutions
- Operator Number
- 10093220
- Address
- 6823 W Post Road, Suite 102
- City
- Las Vegas
- State
- NV
- Postal Code
- 89118
- Country
- US
- Correspondent
- John M Rogers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-06-02 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2025-09-24 |
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2026-04-21 |
Proprietary Names
Actigraft Plus System
bio-ConneKt Wound Matrix
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility