FDA Registration
Active
🇺🇸 United States
VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD)
Reg #: 3004080920
·
FEI: 3004080920
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
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
- K073618
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 Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD)
VERIFY V24 Challenge Pack (LCB005) (PC-MF)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device