Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183828

FEI Number

2183828

Entity Name

STERIS Laboratories

City/State/Country

Brooklyn Park, MN, US

Establishment Address

9303 West Broadway Ave., Brooklyn Park, MN 55445, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 1527821)

Owner / Operator Contact Address

5960 Heisley Rd, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Avita6412 (NT,BP) - RECELL BVI1689 (EP1) - Iris Ring BVI1689 (EP1) - Iris Ring & Inserter MicroSurg4751 (BP) - Malyugin RIng VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System Carbon5733 (BP) - Agent, Bulking, Injectable for Gastro-Urology Use Avita6412 (BP,NT) - RECELL DelcathSystems6324 (BP) - Delcath Dual Hemofiltration Cartridge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWY	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator	Unknown	Class 3	N/A	2023-10-13
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2012-12-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2014-03-03
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2022-12-15
QCZ	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator	Unknown	Class 3	N/A	2019-11-01
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2018-01-09
QVG	Embolization Agent, Vascular	Unknown	Class 3	N/A	2025-11-25

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 Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS

Similar Registrations

Registration Number	Establishment Name	Location
2011171	Sterigenics US LLC	Los Angeles, CA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
2029412	Avita Medical Americas LLC	Ventura, CA, US
3014270795	AVITA MEDICAL AMERICAS LLC	Valencia, CA, US
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183828. Last updated year: 2026. Please use registration number 2183828 when referencing this establishment in official correspondence.