STERIS CORPORATION

FDA Device Registration & Listing · Mentor, OH, US · Registration 3004080920

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004080920
FEI Number
3004080920
Entity Name
STERIS CORPORATION
City/State/Country
Mentor, OH, US
Establishment Address
9325 Pinecone Drive, Mentor, OH 44060, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
STERIS Corporation (Owner Number: 10078069)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160908
PMA Number
N/A

All Registered 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) VERIFY Dual Species Self-Contained Biological Indicator 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 Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) 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) VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) VERIFY V24 Challenge Pack (LCB005) (PC-MF) 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) VERIFY Spore Test Strip for S40 Sterilant (LCB001) VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) VERIFY V24 Challenge Pack (LCB005) (PC-MF) SteriScan Steam Integrator (1100EMA) Celerity HP Chemical Indicator Challenge Pack (PCC083) (PC-UMXD) Celerity 20 HP Biological Indicator (LCB044) Celerity HP Challenge Pack (LCB045) Celerity 20 STEAM Biological Indicator (LCB048) ConFirm Rapid 20 Biological Indicators (Hu-Friedy) PRO-LITE Sterilization Tray (PC-RR, SD) 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) VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) VERIFY V24 Challenge Pack (LCB005) (PC-MF) 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 Sterilization Tubing (PC-RR) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR) 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) PRO-LITE Sterilization Tray (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) Celerity 20 HP Biological Indicator (LCB044) 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 VERIFY V24 Biological Challenge Pack (LCB005) (PC-MF) VERIFY V24 Self-Contained Biological Indicator (LCB020) (PC-MF) VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) Celerity 5 HP Biological Indicator (LCB052) Celerity 5 HP Challenge Pack (LCB059) VERIFY Spore Test Strip for S40 Sterilant (LCB001) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Sterilization Tubing (PC-RR) Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR) 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) Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Sterilization Tubing (PC-RR) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR) VERIFY Dual Species Self-Contained Biological Indicator (PC-MF) Vial Activator Set (PC-SD) VERIFY V24 Self Contained Biological Indicator (LCB020) (PC-MF) VERIFY Self-Contained Biological Indicator HP Activator (LCB004) (PC-SD) VERIFY Dual Species Self-Contained Biological Indicator (PC-MF) Celerity 20 HP Biological Indicator (LCB044) Celerity 5 HP Biological Indicator (LCB052) Celerity 5 HP Challenge Pack (LCB059) Celerity 20 HP Challenge Pack (LCB045) VERIFY V24 Self-Contained Biological Indicator (LCB020) Celerity 20 HP Biological Indicator (LCB044) Celerity 5 HP Biological Indicator (LCB052) Celerity 20 HP Biological Indicator (LCB044) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR) Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD) Vis-U-All Low Temperature Sterilization Tubing (PC-RR) Vis-U-All Low Temperature Tyvek Heat Seal Sterilization Pouch (PC-RR) Vis-U-All Low Temperature Tyvek Self Seal Sterilization Pouch (PC-RR)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
OVY Liquid Chemical Processing System General Hospital Class 2 880.6887 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
OVY Liquid Chemical Processing System General Hospital Class 2 880.6887 2024-03-25
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2022-03-29
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-12-11
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-08-25
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-06-26
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-10-22
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2013-02-14
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-06-21
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-09-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2022-09-15
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2021-01-13
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-07-28
OVY Liquid Chemical Processing System General Hospital Class 2 880.6887 2020-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-01-13
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-01-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JRG Block, Heating Clinical Chemistry Class 1 862.2050 2020-10-22
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2023-09-18
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-02-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-09-18
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2026-04-18
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

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K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
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Z-0008-2008 Lemaitre Vascular, Inc. 2
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05 Medrad Inc 2
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004080920. Last updated year: 2026. Please use registration number 3004080920 when referencing this establishment in official correspondence.
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