FDA Registration
Active
🇺🇸 United States
STERIS CORPORATION
Reg #: 3004080920
·
FEI: 3004080920
·
Expires 2026
Products
12
Proprietary Names
123
Establishment Types
6
Classifications
12
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 3004080920
- FEI Number
- 3004080920
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9325 Pinecone Drive
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140494
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 |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2020-10-22 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2020-10-22 |
| Liquid Chemical Processing System | OVY | Class 2 | General Hospital | No | 2020-10-22 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-10-22 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2020-10-22 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2013-02-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-10-22 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2020-10-22 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2020-10-09 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2023-09-18 |
| Indicator, Biological, Liquid Chemical Sterilization Process | MRB | Class 2 | General Hospital | No | 2020-10-22 |
| Qualitative Cleaning Process Protein Indicator | SDC | Class 2 | General Hospital | No | 2024-11-26 |
Proprietary Names
V-PRO Sterilization Tray (PC-RR)
Sterilization Mat (PC-RR)
VERIFY Dual Species Self-Contained Biological Indicator
Celerity 20 HP Challenge Pack (LCB045)
Celerity 20 HP Biological Indicator (LCB044)
Celerity 20 STEAM Process Challenge Device for Gravity Cycles (LCB050)
VERIFY V24 Challenge Pack (LCB005) (PC-MF)
VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD)
VERIFY V24 Self-Contained Biological Indicator (LCB020) (PC-MF)
Vis-U-All Low Temperature Sterilization Tubing (PC-RR)
Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR)
VERIFY V24 Biological Challenge Pack (LCB005) (PC-MF)
VERIFY V24 Self Contained Biological Indicator (LCB020) (PC-MF)
VERIFY Spore Test Strip for S40 Sterilant (LCB001)
Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD)
Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF)
ConFirm Rapid 20 Biological Indicators (Hu-Friedy)
INSTRUMENT ORGANIZER for use with V-PRO Sterilizers (PC-RR, SD)
PRO-LITE Sterilization Tray (PC-RR, SD)
PRO-LITE STERILIZATION TRAY MAT (PC-RR, SD)
SteriScan Steam Integrator (1100EMA)
Celerity HP Chemical Indicator Challenge Pack (PCC083) (PC-UMXD)
Celerity HP Challenge Pack (LCB045)
Celerity 20 STEAM Biological Indicator (LCB048)
PRO-LITE Sterilization Tray Silicone Mats (PC-RR, SD)
Instrument Organizers (PC-RR, SD)
STERIM Self-Contained Biological Indicator (SCBI) (SRI-050) (PC-CM)
Celerity HP Indicator Tape (PCC077) (HP-RR, PC-SD)
VERIFY ASSERT Self-Contained Biological Indicator (LCB031)
VERIFY ASSERT STEAM Process Challenge Device for Dynamic Air Removal (LCB033)
VERIFY ASSERT STEAM Process Challenge Device for Dynamic Air Removal (LCB032)
Celerity 20 STEAM Process Challenge Device for Dynamic Air Removal Cycles (LCB049, LCB053)
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)
Sterilization Tray Silicone Mats (PC-RR)
Celerity 20 HP Biological Indicator (LCB044, LCB045, LCB047)
Celerity 5 HP Biological Indicator (LCB052, LCB059)
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles (LCB043)
Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR)
Merit Intelliflator/Merit Monitor
IntelliSystem
Limited Inflation Syringe
SporView Steam Self-Contained Biological Indicator, SCS-025, SCS-100
SporView@ Steam Self-Contained Biological Indicator, SCS-100
VERIFY Biological Integrator Challenge Packs (S3065, S3069)
Verify Disposable Biological Steam Test Pack (LCB006, LCB007)
Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR, SD)
Vis-U-All Low Temperature Sterilization Tubing (PC-RR, SD)
Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR, SD)
Sterilizable Aluminum Handle for Harmony and HarmonyAIR (MG-RR)
Sterilzable Aluminum Handle with Sterile Surgeon Control (MG-RR)
ROLL-A-SET NEEDLE/PIN HLD 50/BX NE1 (PC-RR)
ROLL-A-SET FOAM ROLL 12/BX NE1 (PC-RR)
ROLL-A-SET 10 POC 25/BX NH1 (PC-RR)
Non-Sterile Disposable Light Handle (MG-RR)
Plastic Handle (MG-RR)
ROLL-A-SET 1 POC 100/BX NJ1 (PC-RR)
ROLL-A-SET 200 POC ROLL 1/BX NG1 (PC-RR)
Silicone Ring (MG-RR)
Alyon Standard Light Handle (MG-MF)
VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-RR, SD)
Verify Steam and EO Integrator (PC-MF)
Verify Steam Sterilizer Load Record (PC-CFE)
Verify Flash Integrator and Patient Record (PC-MF)
Verify Laminated EO Integrator (PC-MF)
Verify Integrator Steam Integrator Strip (PC-MF)
Verify Integrator Steam and EO (Dual) Integrator (PC-MF)
Celerity 20 STEAM Biological Indicator for IUSS
Celerity 5 HP Biological Indicator (LCB052)
Celerity 5 HP Challenge Pack (LCB059)
Vis-U-All Low Temperature Tyvek Sterilization Tubing (PC-RR)
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)
VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF)
Dry Bath Incubator (PC-RR)
VERIFY INCUBATOR (PC-RR)
VERIFY LARGE DUAL INCUBATOR (PC-RR)
VERIFY 6-well Incubator (PC-RR)
VERIFY Dual Species Self-Contained Biological Indicator (PC-MF)
Vial Activator Set (PC-SD)
VERIFY V24 Self-Contained Biological Indicator (LCB020)
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)
V-PRO Sterilization Tray (PC-CFE)
V-PRO Sterilization Tray Organizers (PC-CFE)
Verify HPU Chemical Indicator (PCC061) (LC-MF)
Celerity HP Chemical Indicator (PCC074) (LC-CFE)
Celerity HP Multivariable Chemical Indicator (PCC079) (LC-MF)
Celerity HP Chemical Indicator (PCC075) (LC-MF)
Instrument Organizer Blank, Short (VP0055) (PC-RR, SD)
PRO-LITE Sterilization Mat - VP0071-VP0079 (PC-RR, SD)
Instrument Organizer 11 mm -15 mm Short (VP0063-VP0070) (PC-RR, SD)
PRO-LITE Sterilization Tray - VP0045-VP0053 (PC-RR, SD)
Verify PAA Biological Indicator Kit
Instrument Organizer Blank, Tall (VP0054) (PC-RR, SD)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-SD CFE, MM-RR)
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (LCC101) (PC-SD CFE, MM-RR)
Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-SD CFE, MM-RR)
Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-SD CFE, MM-RR)
VERIFY General Purpose Steam Process Indicator Tape (260010) (MM-RR, PC-SD)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198