FDA Registration
Active
🇺🇸 United States
Viscus Biologics, LLC.
Reg #: 3013012623
·
FEI: 3013012623
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Viscus Biologics, LLC.
- Registration Number
- 3013012623
- FEI Number
- 3013012623
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26309 Miles Road, Suite 1
- City
- Cleveland
- State
- OH
- ZIP
- 44128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170026
Owner / Operator
- Firm Name
- Viscus Biologics LLC
- Operator Number
- 10052742
- Address
- 26309 Miles Road, Suite 1
- City
- Cleveland
- State
- OH
- Postal Code
- 44128
- Country
- US
- Correspondent
- Donna Campbell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2017-06-29 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-06-20 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2016-09-26 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2019-03-19 |
Proprietary Names
Radiopaque Tissue Marker
FibermarX Radiopaque Tissue Marker
BaseMEM
FibermarX
VeraForm Adaptable Tissue Marker
Puracol Ultra Powder
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)