FDA Registration
Active
🇺🇸 United States
biologic material, dental Straumann Emdogain 0.7 ml, Multipack
Reg #: 2024024
·
FEI: 2024024
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sterigenics Radiation Technologies, LLC
- Registration Number
- 2024024
- FEI Number
- 2024024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7695 Formula Pl
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- PMA Number
- P930022
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 |
|---|---|---|---|---|---|
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2012-11-29 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2012-11-29 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2012-11-29 |
Proprietary Names
biologic material, dental Straumann Emdogain 0.7 ml, Multipack
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)