FDA Registration
Active
🇮🇹 Italy
LimaCorpSPA9283 (CC,SR) - Minima S System
Reg #: 3002806470
·
FEI: 3002806470
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- STERIS SPA
- Registration Number
- 3002806470
- FEI Number
- 3002806470
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 29, VIA CA BERTONCINA
- City
- SERIATE Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K141327
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-01-31 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2017-01-31 |
Proprietary Names
LimaCorpSPA9283 (CC,SR) - Minima S System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)