FDA Registration
Active
🇮🇪 Ireland
Zimmer (TL) - Persona Vit E Poly Articular Blocks (MC)
Reg #: 3002807314
·
FEI: 3002807314
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Synergy Health Ireland Ltd
- Registration Number
- 3002807314
- FEI Number
- 3002807314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- IDA Business and Technology Park
- City
- Tullamore Offaly
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K150090
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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2017-08-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-08-04 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2017-08-04 |
Proprietary Names
Zimmer (TL) - Persona Vit E Poly Articular Blocks (MC)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)