FDA Registration
Active
🇺🇸 United States
Imaging System
Reg #: 1061124
·
FEI: 1000512168
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1061124
- FEI Number
- 1000512168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10821 Withers Cove Park Dr
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123108
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Plaque Morphology Evaluation | OGZ | Class 2 | Cardiovascular | No | 2023-06-13 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2023-06-13 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-06-13 |
Proprietary Names
Imaging System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)