Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680143

FEI Number

3002807308

Entity Name

STERIS Applied Sterilization Technologies ULC

City/State/Country

WHITBY Ontario, CA

Establishment Address

184 CROWN CT., WHITBY Ontario L1N 7B1, CA

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

DermaSci1232 (WT) - oil emulsion DermaSci1232 (WT) - honey alginate DermaSci1232 (WT) - Medihoney Hydrogel Colloidal Sheet DermaSci1232 (WT) - sterile water DermaSci1232 (WT) - sterile saline MML1375 (SN) - MML Specimen Collection Swab Ensera7760 (GR,SP) - Sterile Flocked Swab Ensera7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab Ensera7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2 Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle Puritan5503 (NR) - Sterile Foam Tipped Applicator Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators Robling1585 (SP) - ClearTip Swab Ultra Thin Birchwood1772 (MN) - Scopettes JR Puritan5503 (NR) - Sterile Cotton Tipped Applicators Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators DermaSci1232 (WT) - Medihoney Honeycolloid Dressing Pretium1202 (WT)- Starplex Starswab 2 Bacteriology Culture Collection BactiSwab LiquidFisherfinest Bacteriology Culture VerathonMedical5877 (WT) - GlideScope Ranger Single Use VerathonMedical5877 (WT) - GlideScope AVL Single Use VerathonMedical5877 (WT) - GlideScope GVL Single Use DermaSci1232 (WT,LN) - Medihoney DermaSci1232 (WT) - petrolatum DermaSci1232 (WT) - Xeroform DermaSci1232 (WT) - suture strips plus DermaSci1232 (WT) - Wound Closure Strips DermaSci1232 (WT) - Shur Strip DermaSci1232 (WT) - iodoform guaze

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-27
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2019-12-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-27
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2018-04-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-12-27
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2012-11-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2024-01-02
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2012-10-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-01-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-10-23
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2020-10-23
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2019-10-31
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-03-03
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-01-28
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-27
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2019-12-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-12-27
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2012-12-27
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2019-12-27
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2019-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: becky_aldhizer@steris.com Phone: (440) 4687462

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680143. Last updated year: 2026. Please use registration number 9680143 when referencing this establishment in official correspondence.