FDA Registration
Active
🇨🇦 Canada
Sterigenics EO Canada, Inc.
Reg #: 9611665
·
FEI: 3002807095
·
Expires 2026
Products
60
Proprietary Names
322
Establishment Types
1
Classifications
60
Registration Details
- Registration Name
- Sterigenics EO Canada, Inc.
- Registration Number
- 9611665
- FEI Number
- 3002807095
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400 Ambassador Drive
- City
- Mississauga Ontario
- Country
- CA
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2013-04-17 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2025-07-30 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2023-11-09 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2023-11-09 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-11-09 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2013-07-25 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2025-08-01 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2014-07-08 |
| Dual Lumen Ecmo Cannula | PZS | Class 2 | Cardiovascular | No | 2024-12-12 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2013-05-02 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-11-15 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-07-25 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-07-25 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2013-07-25 |
| Culture Media, Anaerobic Transport | JSL | Class 1 | Microbiology | No | 2013-07-25 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2013-07-25 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2017-07-05 |
| Oxygenator, Long Term Support Greater Than 6 Hours | BYS | Class 2 | Cardiovascular | No | 2024-12-12 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2024-12-12 |
| Tubing, Long Term Support Greater Than 6 Hours | QWF | Class 2 | Cardiovascular | No | 2024-12-12 |
| Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | QJZ | Class 2 | Cardiovascular | No | 2024-12-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-12 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2013-04-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-07-05 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2019-07-02 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-11-09 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2025-07-09 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-07-30 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-07-17 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2013-04-23 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2013-07-25 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2012-12-14 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2025-07-30 |
| Implant, Absorbable, (Scleral Buckling Methods) | HQJ | Class 2 | Ophthalmic | No | 2012-12-10 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2013-07-25 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2014-07-08 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-11-15 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2024-12-12 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Clamp, Line | FKK | Class 1 | Gastroenterology, Urology | No | 2013-07-25 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2013-07-25 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2023-08-17 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-08-17 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-08-17 |
| Optical Coherence Tomography, Intravascular Catheter | ORD | Class 2 | Cardiovascular | No | 2023-08-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-07-25 |
| Apparatus, Cautery, Radiofrequency, Ac-Powered | HQR | Class 2 | Ophthalmic | No | 2013-07-25 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2012-11-01 |
| Crutch, Ptosis | HJZ | Class 1 | Ophthalmic | No | 2013-07-25 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-10-31 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2017-07-05 |
| Burr, Corneal, Battery-Powered | HOG | Class 1 | Ophthalmic | No | 2013-07-25 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2013-04-23 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-11-01 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2017-07-18 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2013-07-25 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2025-07-30 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2025-07-30 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-07-30 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2012-11-19 |
Proprietary Names
BD Luer Accessories
Kangaroo Milk Straw: 462000E
Kangaroo Milk Straw: 461000E
Kangaroo Milk Straw: 464000E
LUNA-100
Dual Floating Dialysis catheter
OWL STERILE SINGLE USE CANNULAE
FALLER STYLET
Crescent Right Atrial
Visitec
Crawford Intubation
Lumohs Loader
Lumohs Scalpel
Blade, Scalpel
BEAVER NEEDLE BLADE 1.5MM CUTTING EDGE
BEAVER CATARACT BLADE 19MM L X 1.4MM W
BEAVER SCLEROTOME KNIFE SHARP ALL AROUND
BEAVER TYMPANOPLASTY BLADE 2.5MM W 60 BEVEL DOWN
BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE
BEAVER BENT BLADES 45 SHARP ALL AROUND
BEAVER OPTIMUM BLADE 22.5 STRAIGHT
BEAVER NEEDLE BLADE 5MM CUTTING EDGE
BEAVER TYMPANOPLASTY BLADE 2MM W 50 BEVEL DOWN
BEAVER SICKLE EDGE BLADE 5MM
BEAVER ARTHRO-LOK POINTED RETROGRADE 4MM BLADE
BEAVER NEEDLE BLADE 3MM CUTTING EDGE
BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE (FLAT)
BEAVER SLIT BLADE 1.5MM STRAIGHT
BEAVER POCKET SCLERAL KNIFE 3MM 60
BEAVER CATARACT BLADE 20.5MM L X 1.7MM W
BEAVER POCKET BLADE 3MM W 60 BEVEL DOWN
BEAVER OPTIMUM BLADE 45 STRAIGHT
BEAVER OPTIMUM BLADE 15 STRAIGHT
BEAVER MINI-BANANA BLADE (FLAT) 4MM
BEAVER SCLEROTOME BLADE MULTI-SIDED
BEAVER BLADE
BEAVER BEAVERGUARD GUARDED .50MM DEPTH BLADE
BEAVER MINI-BLADE SURGICAL BLADE 180
BEAVER ARTHRO-LOK HOE 60 4MM BLADE
BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE (FLAT)
BEAVER ARTHRO-LOK MINI-BANANA 4MM BLADE
BEAVER NEEDLE BLADE 7MM CUTTING EDGE
BEAVER CATARACT BLADE 25.5MM L X 2.2MM W
BEAVER SLIT BLADE 3MM 45 BEVEL UP
BEAVER BEAVERGUARD GUARDED .35MM DEPTH BLADE
BEAVER SLIT BLADE 3MM STRAIGHT
BEAVER POCKET CRESCENT BLADE 2.5MM 55 BEVERL UP
BEAVER OPTIMUM BLADE 30 STRAIGHT
BEAVER SLIT BLADE 3MM 45 BEVEL DOWN
BEAVER SLIT BLADE 3.2MM 45 BEVEL DOWN
BEAVER ARTHRO-LOK POINTED TIP CURVE L 4MM BLADE
BEAVER POCKET BLADE 2.25MM W 60 BEVEL UP
BEAVER CERVICAL BIOPSY BLADE
BEAVER MICRO-BLADE 15
BEAVER TYMPANOPLASTY BLADE 2.5MM W STRAIGHT
BEAVER SLIT BLADE 2.8MM 45 BEVEL DOWN
BEAVER MICRO-BLADE 30
BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE
DermaPlane
BEAVER POCKET SCLERAL KNIFE 2.25MM 60
BEAVER ARTHRO-LOK BANANA 4MM BLADE
BEAVER ARTHRO-LOK RETROGRADE 4MM BLADE
BEAVER ARTHRO-LOK ROSETTE 4MM BLADE
DermaBlade
Surgical 15 blades
Dermaplane 10S bladkes
Surgical 11 blades
Surgical 10 blades
Single Use #11 Safety Scalpel
Single Use #15 Safety Scalpel
Safety Cartridge #11 Carbon Steel Blade Orange Cartridge
Safety Cartridge #10 Stainless Steel Blade Green Cartridge
Safety Cartridge #15 Carbon Steel Blade Red Cartridge
Argon Medical Scalpels
Safety Cartridge #10 Carbon Steel Blade Purple Cartridge
Safety Cartridge #11 Stainless Steel Blade Blue Cartridge
Safety Cartridge #15 Stainless Steel Blade Yellow Cartridge
Single Use #10 Safety Scalpel
Short/Long Handle Scalpels
Safety scalpel
Scalpel Blades
Phlebotomy Bag Sets
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
Starswab Anaerobic Transport System
Labtician Lid Load
CANNULA SEAL,ENDOWRIST STAPLER,IS3000 (PN 410351-03)
VitalFlow Set
KA2210/25
KA2110/50
TRU-FIX Catheter Fixation Kit
KA1224/50
KA2210/50
KA1154/25
KA2254/25
KA1124/100
KA2310W/25
KA2154/50
MTS003/100
KA2130/50
KA1124/25
Zip DS Dressing Shield
Bandages
KA1118/50
KA2211/25
KA1254/25
OPSITE, IV3000 Frame Delivery
COVRSITE Plus
OPSITE, IV3000 1-Hand
Breg
OPSITE, IV3000 1-Hand Ported
OPSITE Post Op, IV 3000
OPSITE Flexigrid, IV3000 Standard
Skin Fix
OPSITE Flexigrid, IV3000 Ported
Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001
Incise Film
BAND-AID® Brand TOUGH STRIPS® Bandages
TrialOn
BAND-AID® Brand Flexible Fabric Bandages
Tube Holder 100/case
Tube Holder White
Dressings (Breg)
SureSeal Pressure Bandage
Primapore
CovRsite
Arctic Front cardiac cryoablation catheter
Freezor MAX Cardiac Cryoablation Catheter
Freezor MAX cardiac cryoablation catheter
Arctic Front Advance cardiac cryoablation catheter
ASSY,FENESTRATED BIPOLAR FORCEPS,SINGLE SITE,6-PAK (PN 428093-13)
Xi Single Site Fenestrated Bipolar Forceps - 478093
SINGLE-SITE PORT,8.5MM ENDO,BOX OF 10 (PN 428065-03)
Pristine Arthroscopic Visualization System
Summit Arthroscope
329.634S
329.632S
3601S
351.27S
329.633S
35986S
35113S
PLASTIC TEMPLATE FOR CATHETER PLACEMENT
GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (93 X 17IN)
HIGH STRENGTH GUIDE PIN, 14 IN, STERILE, 2.4 X 356MM (93 X 14IN)
HIGH STRENGTH GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN)
LCS PAT PLAN REP BASK STD/STD+
GLOBAL AP BALL CYLIN TRL ASSEM
GLOBAL AP REVISION TRL INSERT
MISHA Knee System Targeting Kit
MISHA Knee System Trial
FlexCath steerable sheath
Noncor Infusion Sets
CRAWFORD LACRIMAL INTUBATION SET (W; T SUTURE); WITHOUT SUTURE)
Crescent Bicaval
Heart Lung Tubing packs
Heart Cooling Jacket
Central Venous Access Tray
Si Cannula Seal - 400077
Si Cautery Spatula, A-Sure (5mm) - 400160
STYLET
Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems
Percutaneous Peritoneal Dialysis Catheter Implantation Systems
Laparoscopic Peritoneal Dialysis Catheter Implantation System
Irrigating Syringe
IRRIGATION TRAY
Thumb control piston irrigation syringe 60cc ST
Flat top piston irrigation syringe 60cc ST
Piston enteral irrigation syringe 60cc NS
Enteral irrigation syringe 60cc NS
EAR BULB SYRINGE
Bulb irrigation syringe 60cc ST
RXP (Rapid Exchange Flushing Syringe
Igloo Wound Irrigation System
Igloo Wound Irrigatior
Standard Trach Care Kit
Soft tray W/ Piston Syringe
ABSCESS CAP
Soft-Flow Aortic
Opus
Valve Adapter
Argyle Penrose Tubing
SuperClip
Accessories, Catheter
Peritoneal Lavage drainage needle/catheter
"Prelude SNAP 165 Valved Splittable Sheath Introducer
Line Clamps
Enema Catheter
Nautilus Base and Smart
Foresight ICE Catheter
Cautery Tip
TIP; WALSH MEDICAL DEVICES INC. CAUTERY
Suction conneting tube
Aspiration Tubing
OWL STERILE SINGLE USE PROBES
Wright Ptosis Support Sling
EndoRelease Cubital Tunnel Release System
Hex-Flex with disposable obturalor
DryDoc Cannula
Reprocessed Arthroscopic Accessories
Hi-Flow Cannula
FlowPort Cannula
SharpShooter Handle
Universal Cannula
SafeGuard Carpal Tunnel Release System
INTEQ Suturing kit
Hex-Flex Disposable Cannula
Hip Preservation Sys
Cannula, Cannuloc, disposable
Scope Shield
Blitz Suture Retriever
Astroscopy Cannula
CapsulePass Suture Passer
Ceterix Disposable Knot Pusher
TwoVu ST-6-134
FirstPass ST Suture Passer, Self Capture
TwoVu ST-5
ClearVu 2.7 Blunt
Exstravastopper
FirstPass ST Suture Passer, Standard
TwoVu ST-6L
Y-KNOT FLEX HIP DISPOSABLE FLEXIBLE OBTURATOR, BLUNT
TwoVu ST-6
Y-Knot
HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8 X 85MM, QTY 6
Integra Endorelease Cubital Tunnel Release System
8 X 120MM HIP PRESERVATION SYSTEM ARTHROSCOPY CANNULA, QTY 6
5.5MM (I.D.) X 70MM SHOULDER CANNULA SET WITHOUT FENESTRATIONS, 10 EA
8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
ClearVu 2.7 Sharp
DryVu
BLITZ SUTURE RETRIEVER, STRAIGHT, 6 EA
5.5MM (I.D.) X 70MM UNIVERSAL CANNULA SET WITH FENESTRATIONS, 10 EA
6.5 X 73MM CLEAR FLEXIBLE CANNULA, 6 EA
Adjustable Retractor Cannula 6mm x 65mm
DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 85MM, QTY 6
Y-Knot, Flex Disposable Flexible, Trocar
Adjustable Retractor Cannula 6mm x 85mm with outflow
DRY DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 75MM, QTY 6
HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 7 X 85MM, QTY 6
6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
TwoVu ST-6-130
CANN DRY DOC 8.4X75MM 6 EA
8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA
HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6
DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6
8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
Adjustable Retractor Cannula 8mm x 65mm
8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA
CrossFix II Disposable Kit
DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 6 X 85MM, QTY 6
6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA
8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
HIP PRESERVATION SYSTEM HIP ACCESS NEEDLE PACK, 17G, QTY 2
6MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
HEX-FLEX CANNULA WITH DISPOSABLE OBTURATOR 6 X 85MM, QTY 6
6.5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED, QTY 6
6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA
Y-Knot, Flex Disposable Flexible Obturator, Blunt
DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 95MM, QTY 6
8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA
DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 85MM, QTY 6
6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA
HIP PRESERVATION SYSTEM SWITCHING STICK PACK, QTY 1
Adjustable Retractor Cannula 8mm x 85mm
0234-020-165;3910-075-500;3910-075-501;3910-075-650;3910-075-651;3910-075-800;3910-090-650;3910-090-800
Arthroscopic Accessories
Cubital Tunnel Release System
EGR System
Accessories, Arthroscopic
MicroAire Endoscopic Release System - Various Accessories
3910-090-500
3910-075-801
Remote Control Drape
Sharpshooter
Endoscopic Gastroc Release (EGR) System
Dry Doc Cannula W/Disp. Obturator
Disposable Cannula
Flexible Cannula
CMI Measuring Rod (dose audit)
CMI Measuring Rod (Production)
Dry Dooc Cannula, Non Fenestrated
Cannuloc, disposable cannula
Xi Conductive Reducer - 470381
Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09)
Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07)
Si Stapler Sheath - 410370
Xi Stapler 45 Reload (Blue) - 48645B
Xi Seal (12mm & Stapler) - 470380
12 mm & Stapler Cannula Seal - 470380
Xi Stapler 45 Reload (White) - 48645W
Xi Stapler 45 Reload (Green) - 48445G
Freezor MAX Surgical Cardiac cryoablation catheter
Freezor Cardiac Cryoablation Catheter
Freezor Xtra Surgical cardiac cryoablation catheter
8mm Stinger, Stinger S, Stinger M, Stinger SM and 8mm Scorpion 2 & Scorpion 2 M Distal Tip Ablation Catheters
HD Mesh Ablator Cables, Over-the-Wire Mesh Ablator Cables & Encompass Ablator Cables
Over-the-Wire Mesh Ablator Guide Wire 5-Pack & Encompass Guide Wire 5-Pack
HD Mesh Ablator Diagnostic and Ablation Catheters, Over-the-Wire Diagnostic and Ablation Catheter and Guide Wire Kit & E
Freezor Xtra Cardiac Cryoablation Catheter
Freezor cardiac cryoAblation catheter
Stainless Steel Instruments
Xpansion® Forceps
DTRAX Spinal System
Soft-Flow Extended
Light Probe
Lacrimal Light Probe Fiberoptic
Stand for Infusion
Argyle Specimen Traps
Argyle Lukens Specimen Container
Argyle Specimen Traps: 3583MST7000
Bronchitrac
Argyle Specimen Traps: 8884724000
Argyle Specimen Traps: 3583MST4000
Argyle Specimen Traps: 8884724504
Argyle Lukens Specimen Container: 8888258608
Argyle Specimen Traps: 8884724500
Catheters, Suction, Tracheobronchial Bronchitrac
Closed Suction System
CAM Catheter; Complete Airway Management Catheter, CAM Rescue Cath
Intuitive Surgical EndoWrist One Vessel Sealer
Si Vessel Sealer - 410322
ASSEMBLY,VESSEL SEALING,IS3000,6-PACK (PN 410322-04 and 05)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)