FDA Registration
Active
🇺🇸 United States
RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR)
Reg #: 1933443
·
FEI: 1000510740
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 1933443
- FEI Number
- 1000510740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8525 Page Ave
- City
- Breckenridge Hills
- State
- MO
- ZIP
- 63114
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232918
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 |
|---|---|---|---|---|---|
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | Class 2 | Gastroenterology, Urology | No | 2023-10-22 |
Proprietary Names
RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR)
enspire 300 Series Automated Endoscope Reprocessor (QB-MF)
enspire 300 Series Connectors (HP-MF)
RevitalOx PAA HLD Solution Part A (MM-MF)
Establishment Types
Repack or Relabel Medical Device