FDA Registration
Active
🇺🇸 United States
VERIFY ASSERT Self-Contained Biological Indicator (LCB031)
Reg #: 3004080920
·
FEI: 3004080920
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 3004080920
- FEI Number
- 3004080920
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9325 Pinecone Drive
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200126
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 |
|---|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2020-10-22 |
Proprietary Names
VERIFY ASSERT Self-Contained Biological Indicator (LCB031)
VERIFY ASSERT STEAM Process Challenge Device for Dynamic Air Removal (LCB032)
VERIFY ASSERT STEAM Process Challenge Device for Dynamic Air Removal (LCB033)
Establishment Types
Manufacture Medical Device