FDA Registration
Active
🇺🇸 United States
Isomedix Operations, Inc.
Reg #: 2183744
·
FEI: 2183744
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2183744
- FEI Number
- 2183744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 380 90TH AVE NW
- City
- Minneapolis
- State
- MN
- ZIP
- 55433
- Country
- US
Regulatory Submissions
- 510(k) Number
- K991670
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 |
|---|---|---|---|---|---|
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2012-12-18 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)