FDA Registration
Active
🇺🇸 United States
VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE)
Reg #: 3007412809
·
FEI: 3007412809
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 3007412809
- FEI Number
- 3007412809
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11457 MELROSE AVE
- City
- FRANKLIN PARK
- State
- IL
- ZIP
- 60131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152630
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, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-10-12 |
Proprietary Names
VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE)
VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB037) (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB036) (FP-MF, HP-MF)
VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack (LCB035) (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device