STERIS Corporation

FDA Device Registration & Listing · FRANKLIN PARK, IL, US · Registration 3007412809

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
3007412809
FEI Number
3007412809
Entity Name
STERIS Corporation
City/State/Country
FRANKLIN PARK, IL, US
Establishment Address
11457 MELROSE AVE, FRANKLIN PARK, IL 60131, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
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
N/A
PMA Number
N/A

All Registered Proprietary Names

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) 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) 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 All-In-One PV10 Assembly (LCB042) (FP-CFE) Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB056) (FP-MF, HP-MF) VERIFY All-In-One Steam Reusable Test Pack with Tag (LCB057) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) SteriScan Six Emulating Indicator (2200 and 2201) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) SteriScan Reusable Test Pack (5500) (FP-CFE) 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) Informer Med Steam PCD (FP-CFE) SteriScan Reusable Test Pack (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE) 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) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) SteriScan Reusable Bowie Dick Test Pack (5500) (FP-CFE) SteriScan Reusable Test Pack (3300NC) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) VERIFY STEAM INTEGRATING INDICATOR 5CM (PCC067) (FP-MF, HP-MF) VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (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) 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 STEAM Integrating Indicator (PCC064 PCC065 PCC066) (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) SteriScan Steam Integrator (1100EMA) Celerity HP Chemical Indicator Challenge Pack (PCC083) (PC-UMXD)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2020-10-12
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 2020-10-12
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 2020-10-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
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 2020-10-12
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 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151482 Bcr Diagnostics, Inc. BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 2016-02-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007412809. Last updated year: 2026. Please use registration number 3007412809 when referencing this establishment in official correspondence.
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