FDA Registration
Active
🇺🇸 United States
STERIS Corporation
Reg #: 3000251274
·
FEI: 3000251274
·
Expires 2026
Products
9
Proprietary Names
133
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- STERIS Corporation
- Registration Number
- 3000251274
- FEI Number
- 3000251274
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6515 HOPKINS RD.
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231488
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 | 2023-09-18 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2023-09-18 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2020-10-13 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2020-10-12 |
| Accessories, Cleaning, For Endoscope | FEB | Class 2 | Gastroenterology, Urology | No | 2025-03-23 |
| Endoscope Maintenance System | PUP | Class 2 | Gastroenterology, Urology | No | 2024-03-13 |
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | Class 2 | Gastroenterology, Urology | No | 2023-10-22 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2020-10-09 |
| Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | OWP | Class 2 | General Hospital | No | 2020-10-22 |
Proprietary Names
Verify HPU Chemical Indicator (PCC061) (LC-MF)
Celerity HP Chemical Indicator (PCC074) (LC-CFE)
Celerity HP Multivariable Chemical Indicator (PCC079) (LC-MF)
Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD)
Celerity HP Chemical Indicator (PCC075) (LC-MF)
S40 Sterilant Concentrate (MM-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE)
SYSTEM 1 endo Quick Connects (HP-MF, CM-SD)
SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD)
VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD)
VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD)
SteriScan Reusable Test Pack without Counter (3306NC) (FP-CFE)
VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF)
VERIFY SixCess MF4 STEAM Emulating Indicator (FP-CFE)
SteriScan Reusable Test Pack with Counter (3306) (FP-CFE)
SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD)
SYSTEM 1E Trays and Containers (QB-MF, CM-SD)
SYSTEM 1E Quick Connects (HP-MF, CM-SD)
SteriScan Reusable Test Pack (5500) (FP-CFE)
VERIFY Bowie Dick Test Card (S3095) (HP-MF)
VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF)
Celerity Xtend 10 Assembly (LCB054) (PC-CFE)
VERIFY All-In-One Steam Reusable Test Pack with Tag (LCB057) (FP-MF, HP-MF)
VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE)
VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB056) (FP-MF, HP-MF)
ConFirm Rapid 20 Incubator
VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF)
VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE)
VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB036) (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB037) (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE)
VERIFY All-In-One STEAM Reusable Test Pack (LCB035) (FP-MF, HP-MF)
enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (MM-MF, CM-SD)
enspire 3000 MaxFlow connectors (HP-MF, CM-SD)
VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD)
Reliance 5000 Series Endoscope Storage Cabinet (QB-RR)
Connectors for Reliance 6000 Series Endoscope Storage Cabinet (QB-RR)
Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (HP-MF, PY-SD)
Drying Cabinet Connectors (QB-RR)
AMSCO Drying Cabinets (QB-RR)
Reliance 6500 Series Endoscope Drying and Storage Cabinet (MM-MF, PY-SD)
Reliance 6000 Series Endoscope Storage Cabinet (QB-RR)
Celerity HP Incubator (LCB046)
VERIFY STEAM INTEGRATING INDICATOR 5CM (PCC067) (FP-MF, HP-MF)
MCKESSON INTEGRATORS (FP-MF, HP-MF)
SPS EMULATING INDICATORS (FP-MF, HP-MF)
SPS Henry Schein Integrator (FP-MF, HP-MF)
Hu-Friedy Steam Sterilization Integrator (FP-MF, HP-MF)
SPS ENSURE (FP-MF, HP-MF)
K Dental Indicators (FP-MF, HP-MF)
Patterson Type 5 (FP-MF, HP-MF)
SPS INTEGRATORS (FP-MF, HP-MF)
HENRY SCHEIN MAXITEST INTEGRATORS (FP-MF, HP-MF)
SteriScan Reusable Extended Cycle Test Pack (4400) (FP-CFE)
SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM,HP-CM)
McKesson Steam Integrator (FP-CM,HP-CM)
Henry Schein Integrator (FP-CM,HP-CM)
K-Dental Indicators (FP-CM,HP-CM)
SPS EMULATING INDICATORS (FP-CM,HP-CM)
SPS INTEGRATORS (FP-CM,HP-CM)
SPS ENSURE (FP-CM,HP-CM)
Patterson Type 5 (FP-CM,HP-CM)
HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM)
MCKESSON STERILIZATION INTEGRATOR (FP-CM,HP-CM)
SPS Henry Schein Integrator (FP-CM,HP-CM)
Celerity HP Indicator Tape (PCC077) (HP-RR, PC-SD)
RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR)
enspire 300 Series Connectors (HP-MF)
enspire 300 Series Automated Endoscope Reprocessor (QB-MF)
RevitalOx PAA HLD Solution Part A (MM-MF)
VERIFY RESI-TEST Endo Cleaning Indicator (LCC101) (PC-MF)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-MF)
VERIFY RESI-TEST Swab Cleaning Indicator (LCC100) (PC-MF)
Revital-Ox Single-Ended Channel Brush (2D75QV) (EN-MF)
Instrument Cleaning Brushes, Other (HP-RR)
Revital-Ox Valve/Control Brush (2D78QV) (EN-MF)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-MF)
Cleaning brush - channel (EN-MF)
Cleaning brush - channel - maxi (EN-MF)
Double Header - channel and control head combo (EN-MF)
Revital-Ox Dual-Ended Pull Through Channel Brush (2D76QH) (EN-MF)
Cleaning brush - control head (EN-MF)
Revital-Ox All-In-One Channel and Valve/Control Brush (2D77QH) (EN-MF)
Small Wonder - cleaning brush (EN-MF)
Cleaning brush - channel - enteroscope (EN-MF)
Gemini - double ended - channel (EN-MF)
DuoSwift Cleaning Brush (EN-MF)
Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-MF)
Wooly Brush - channel (EN-MF)
Small Wonder - Double Ended - cleaning brush (EN-MF)
Instrument Cleaning Brushes (S-M) (HP-RR)
Pipe Cleaners (LC-FE)
Celerity Incubator (LCB060)
Celerity Incubator
Celerity STEAM Incubator (LCB051)
Dart Daily Air Removal Test (NB113, NB215) (HP-MF)
Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF)
VERIFY All-In-One Bowie Dick Indicator Strips (FP-MF, HP-MF)
VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB040) (FP-CFE)
SteriScan Reusable Bowie Dick Test Pack (5500) (FP-CFE)
SteriScan Reusable Test Pack (3300NC) (FP-CFE)
SteriScan Steam Integrator (1100EMA)
Celerity HP Chemical Indicator Challenge Pack (PCC083) (PC-UMXD)
Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD)
Celerity 20 STEAM Biological Indicator (LCB063) (PC-UMXD)
Celerity 20 STEAM Process Challenge Device for Dynamic Air Removal Cycles (LCB064, LCB065) (PC-UMXD)
VERIFY SixCess 250F 30 Minute Indicator - Short (PCC005) (LC-MF)
VERIFY SixCess 270F 4 Minute Indicator - Long (PCC008) (LC-MF)
VERIFY SixCess 275F 3 Minute Indicator - Long (PCC034) (LC-MF)
VERIFY SixCess 270F 15 Minute Indicator (PCC031) (LC-MF)
VERIFY SixCess 250F 30 Minute Indicator - Long (PCC007) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Short (PCC037) (LC-MF)
VERIFY SixCess 275F 10 Minute Indicator - Long (PCC033) (LC-CFE)
VERIFY SixCess 270F 4 Minute Indicator - Short (PCC006) (LC-MF)
VERIFY SixCess 270F Flash Indicator (LCC310) (LC-MF)
VERIFY SixCess 275F Flash Indicator (LCC005) (LC-CFE)
VERIFY SixCess 275F 3 Minute Indicator - Short (PCC038) (LC-MF)
Mesa ProChem SSW Steam Integrator (FP-CM, HP-CM)
SteriScan Steam Integrator (1100) (FP-CM, HP-CM)
HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM, HP-CM)
MCKESSON INTEGRATORS (FP-CM, HP-CM)
SPS INTEGRATORS (FP-CM, HP-CM)
Patterson Type 5 (FP-CM, HP-CM)
K Dental Indicators (FP-CM, HP-CM)
SPS ENSURE (FP-CM, HP-CM)
SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM, HP-CM)
SPS Henry Schein Integrator (FP-CM, HP-CM)
Hu-Friedy Steam Sterilization Integrator (FP-CM, HP-CM)
SPS EMULATING INDICATORS (FP-CM, HP-CM)
VERIFY Incubator for VERIFY ASSERT Self Contained Biological Indicator (LCB030)
Informer Med Steam PCD (FP-CFE)
SteriScan Reusable Test Pack (FP-CFE)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only