FDA Registration
Active
🇺🇸 United States
Spectragel
Reg #: 2951203
·
FEI: 1000221490
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOPLEXUS LLC
- Registration Number
- 2951203
- FEI Number
- 1000221490
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5218 N Stockton Hill Road
- City
- Kingman
- State
- AZ
- ZIP
- 86409
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970702
Owner / Operator
- Firm Name
- BIOPLEXUS LLC
- Operator Number
- 9009376
- Address
- 5218 N Stockton Hill Road
- City
- Kingman
- State
- AZ
- Postal Code
- 86409
- Country
- US
- Correspondent
- Rick Dumas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2021-12-30 |
Proprietary Names
Spectragel
Spectragel 2Q
Establishment Types
Manufacture Medical Device