FDA Registration
Active
🇺🇸 United States
SYSTEM 1 endo Quick Connects (HP-MF, CM-SD)
Reg #: 1527821
·
FEI: 1527821
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 1527821
- FEI Number
- 1527821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210737
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 | 2021-05-26 |
Proprietary Names
SYSTEM 1 endo Quick Connects (HP-MF, CM-SD)
SYSTEM 1E Trays and Containers (QB-MF, CM-SD)
SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD)
S40 Sterilant Concentrate (MM-MF, CM-SD)
SYSTEM 1E Quick Connects (HP-MF, CM-SD)
SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility