FDA Registration
Active
🇬🇧 United Kingdom
3322040 DePuy CMW 2 Bone Cement
Reg #: 3015219237
·
FEI: 3015219237
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIGENICS UK LIMITED
- Registration Number
- 3015219237
- FEI Number
- 3015219237
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 13a, Seymour Link Road
- City
- Markham Vale Derbyshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K053003
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 |
|---|---|---|---|---|---|
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2013-02-01 |
Proprietary Names
3322040 DePuy CMW 2 Bone Cement
3312020 DePuy CMW 1 Bone Cement
3312040 DePuy CMW 1 Bone Cement
3332020 DePuy CMW 3 Bone Cement
3332040 DePuy CMW 3 Bone Cement
3322020 DePuy CMW 2 Bone Cement
DePuy CMW 1 Bone Cement
DePuy 3 CMW Bone Cement
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)