FDA Registration
Active
🇺🇸 United States
Isomedix Operations Inc.
Reg #: 2246552
·
FEI: 2246552
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2246552
- FEI Number
- 2246552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3459 SOUTH CLINTON AVE.
- City
- S Plainfield
- State
- NJ
- ZIP
- 07080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193105
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-12-04 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2020-12-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2020-12-04 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-12-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-12-04 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)