FDA Registration
Active
🇺🇸 United States
Biodrain streamway fluid management system
Reg #: 3008363932
·
FEI: 3008363932
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEACOLE-CRC, LLC
- Registration Number
- 3008363932
- FEI Number
- 3008363932
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13505 Industrial Park Blvd.
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090759
Owner / Operator
- Firm Name
- Seacole-CRC, LLC
- Operator Number
- 10079585
- Address
- 13505 Industrial Park Blvd.
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
- Correspondent
- Sara Ethier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2024-09-24 |
Proprietary Names
Biodrain streamway fluid management system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)