FDA Registration
Active
🇺🇸 United States
ISOMEDIX OPERATIONS INC.
Reg #: 1720929
·
FEI: 1720929
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1720929
- FEI Number
- 1720929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9120 SOUTH 150 EAST
- City
- Sandy
- State
- UT
- ZIP
- 84070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150105
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2015-12-21 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)