FDA Registration
Active
🇺🇸 United States
Sterigenics U.S. LLC
Reg #: 1054811
·
FEI: 1000114185
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S. LLC
- Registration Number
- 1054811
- FEI Number
- 1000114185
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 502 Prairie Mine Rd
- City
- MULBERRY
- State
- FL
- ZIP
- 33860
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170382
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-11-15 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)