FDA Registration
Active
🇺🇸 United States
VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF)
Reg #: 3000251274
·
FEI: 3000251274
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 3000251274
- FEI Number
- 3000251274
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6515 HOPKINS RD.
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162758
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 | 2020-10-09 |
Proprietary Names
VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Long (PCC033) (LC-CFE)
VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD)
VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD)
VERIFY SixCess 270F Flash Indicator (LCC310) (LC-MF)
VERIFY SixCess 270F 4 Minute Indicator - Long (PCC008) (LC-MF)
VERIFY SixCess 270F 15 Minute Indicator (PCC031) (LC-MF)
VERIFY SixCess 250F 30 Minute Indicator - Long (PCC007) (LC-MF)
VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD)
VERIFY SixCess 270F 4 Minute Indicator - Short (PCC006) (LC-MF)
VERIFY SixCess 275F Flash Indicator (LCC005) (LC-CFE)
VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-SD)
VERIFY Bowie Dick Test Pack (EQC010) (HP-CFE)
VERIFY SixCess 275F 3 Minute Indicator - Short (PCC038) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Short (PCC037) (LC-MF)
VERIFY SixCess 275F 3 Minute Indicator - Long (PCC034) (LC-MF)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198