FDA Registration
Active
🇺🇸 United States
STERIS Corporation
Reg #: 1526531
·
FEI: 1526531
·
Expires 2026
Products
7
Proprietary Names
23
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 1526531
- FEI Number
- 1526531
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17820 ENGLEWOOD DR.
- City
- CLEVELAND
- State
- OH
- ZIP
- 44130
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112535
Owner / Operator
- Firm Name
- STERIS
- Operator Number
- 10091086
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-06-27 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2024-06-27 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2024-06-27 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-06-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-06-27 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2024-06-27 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2024-06-27 |
Proprietary Names
V. Mueller Genesis Containers (CL-MF,RR, ST-SD)
V. Mueller Neuro/Spine VERSA-TRAC (CL-RR, ST-RR)
V. Mueller Retraction and Distraction Platforms (CL-RR, ST-MF,RR)
V. Mueller Neuro/Spine Shadow-Line (CL-RR, ST-SD)
V. Mueller Instrument Care Emesis Basin (CL-RR, ST-CFE)
V. Mueller Genesis Low Temperature Reusable Rigid Container System (CL-RR, MF, ST-SD)
Genesis Container Systems (CL-MF,RR, ST-SD)
V. Mueller Genesis Reusable Sterilization Container System (CL-MF, ST-SD)
DePuy Synthes Sterilization Container System (CL-CM)
Genesis Container Systems (CL-RR, ST-SD, CFE)
V. Mueller Cassettes and Trays (CL-RR)
Genesis Reusable Rigid Sterilization Container System (CL-MF,RR, ST-SD)
Genesis containers (CL-MF,RR, ST-SD)
V. Mueller Basket Tag (CL-RR, ST-MF)
V. Mueller Color Plate (CL-RR, ST-MF)
V. Mueller Instrument Care (CL-RR, ST-CFE)
V. Mueller Weisenbach Sterile Forceps (WM-FE,RR)
V. Mueller Paparella Sterilizable Case (ST-MF)
V. Mueller Instrument Racks (ST-MF)
V. Mueller Instrument Holders (ST-MF)
V. Mueller (CL-RR, ST-MF, SD, WM-FE,RR)
Synthes Reusable Sterilization Container System (CL-CM)
Sterilization Process Indicator (CL-RR, ST-CFE)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)