FDA Registration
Active
🇺🇸 United States
Sterigenics U.S., LLC
Reg #: 1036836
·
FEI: 1036836
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1036836
- FEI Number
- 1036836
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1148 Porter Ave
- City
- Haw River
- State
- NC
- ZIP
- 27258
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230865
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 |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2024-02-09 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)