FDA Registration
Active
🇺🇸 United States
60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,
Reg #: 3002907620
·
FEI: 3002907620
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 3002907620
- FEI Number
- 3002907620
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1700 College Blvd.
- City
- West Memphis
- State
- AR
- ZIP
- 72301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K053445
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 |
|---|---|---|---|---|---|
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2013-01-31 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2013-01-31 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2013-01-31 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2013-01-31 |
Proprietary Names
60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,
80g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,
SmartMix Cemvac with SmartSet HV Bone Cement
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)