FDA Registration
Active
🇺🇸 United States
Medtronic Instrument
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029275
- FEI Number
- 1000306431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 344 Bonnie Cir
- City
- Corona
- State
- CA
- ZIP
- 92878
- Country
- US
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 |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-10-30 |
Proprietary Names
Medtronic Instrument
Kyphon Xpander II Inflatable Bone Tamps
Kyphon Express II Inflatable Bone Tamps
KyphoPak Xpander II and Express II First Fracture and Additional Fracture Trays
MSB METRx System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)