FDA Registration
Active
🇺🇸 United States
SPS-1®, Static Preservation Solution
Reg #: 3004068499
·
FEI: 3004068499
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORGAN RECOVERY SYSTEMS, INC.
- Registration Number
- 3004068499
- FEI Number
- 3004068499
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- One Pierce Place, Suite 475W
- City
- Itasca
- State
- IL
- ZIP
- 60143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091656
Owner / Operator
- Firm Name
- ORGAN RECOVERY SYSTEMS, INC.
- Operator Number
- 9056483
- Address
- One Pierce Place, Suite 475W
- City
- Itasca
- State
- IL
- Postal Code
- 60143
- Country
- US
- Correspondent
- Stanley J Harris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Perfusion, Kidney, Disposable | KDL | Class 2 | Gastroenterology, Urology | No | 2010-12-27 |
Proprietary Names
SPS-1®, Static Preservation Solution
Establishment Types
Manufacture Medical Device