FDA Registration
Active
🇺🇸 United States
S40 Sterilant Concentrate (MM-MF, CM-SD)
Reg #: 3003950207
·
FEI: 3003950207
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 3003950207
- FEI Number
- 3003950207
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6100 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113520
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2020-10-13 |
Proprietary Names
S40 Sterilant Concentrate (MM-MF, CM-SD)
SYSTEM 1E Quick Connects (HP-MF, CM-SD)
SYSTEM 1E Trays and Containers (QB-MF, CM-SD)
SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD)
Establishment Types
Manufacture Medical Device