Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1937531

FEI Number

1937531

Entity Name

STERIS CORPORATION

City/State/Country

Saint Louis, MO, US

Establishment Address

7501 Page Ave, Saint Louis, MO 63133, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240075

PMA Number

N/A

All Registered Proprietary Names

Prolystica Multi-Enzymatic Cleaner (1C38) Prolystica 100 PID Prion Inactivating Detergent 8E-Zyme Cleaner 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) Revital-Ox Rigid Container System (2D93Q0) (SL-CFE, SLDC-RR) Revital-Ox Flexible Container - Round (2D94Q0) (SL-CFE, SLDC-RR) Revital-Ox Resert High Level Disinfectant (SL-MF, SLDC-RR) enspire 300 Series Connectors (HP-MF) RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF) Prolystica Pass-Thru Disinfectant Wipes (1C061D) (SL-SD, SLDC-RR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2020-10-10
NZA	Accessories, Germicide, Cleaning, For Endoscopes	Gastroenterology, Urology	Class 2	876.1500	2023-10-22
PHT	Basin For Endoscope Reprocessing	Gastroenterology, Urology	Class 1	876.1500	2021-11-14
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2020-10-09
NZA	Accessories, Germicide, Cleaning, For Endoscopes	Gastroenterology, Urology	Class 2	876.1500	2023-09-15
SHM	N/A	N/A	Class N/A	N/A	2026-06-05

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
K033381	Discus Dental, Inc.	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	2004-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number	Establishment Name	Location
3008993611	P & T MEDICAL	Ningbo Zhejiang, CN
2518690	Keystone Industries - Delran	Delran, NJ, US
1000355982	ARMSTRONG MANUFACTURING INCORPORATED	Mississauga Ontario, CA
3007697908	Novapharm Research Australia Pty Ltd	Rosebery New South Wales, AU
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1937531. Last updated year: 2026. Please use registration number 1937531 when referencing this establishment in official correspondence.