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
Indicator, Physical/Chemical Sterilization Process JOJ

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