Contract sterilizerSterigenics U.S., LLC (Ontario, CA)CaliforniaAnesthesiologyGeneral hospitalClinical chemistryCardiovascularEar, nose and throatGastroenterology and urologyPathologyGeneral and plastic surgeryHematologyObstetrics and gynecologyOphthalmicOrthopedicPhysical medicineDentalRadiologyNeurologyClass IClass IIUnclassifiedNot classified
Sterigenics U.S., LLC
Contract sterilizer · Ontario, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2029015 (openFDA record; or search FDA's registration database)
- FEI number
- 1000160458
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 687 S Wanamaker Ave, Ontario, CA 91761
- Contract listings
- 188 device listings, 128 product codes, first listed Jun 15, 2009
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Class I | Anesthesiology | Contract sterilization | Nov 19, 2012 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Class II | Anesthesiology | Contract sterilization | May 14, 2013 |
| BYZ | Trap, Sterile Specimen | Class II | General hospital | Contract sterilization | May 19, 2016 |
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | Contract sterilization | Jul 7, 2017 |
| BZQ | Monitor, Breathing Frequency | Class II | Anesthesiology | Contract sterilization | May 14, 2013 |
| CAC | Apparatus, Autotransfusion | Class II | Anesthesiology | Contract sterilization | Jun 27, 2023 |
| CAZ | Anesthesia Conduction Kit | Class II | Anesthesiology | Contract sterilization | Aug 23, 2013 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | Class I | Clinical chemistry | Contract sterilization | Nov 30, 2012 |
| DPZ | Oximeter, Ear | Class II | Cardiovascular | Contract sterilization | May 14, 2013 |
| DQA | Oximeter | Class II | Cardiovascular | Contract sterilization | May 14, 2013 |
| DRC | Trocar | Class II | Cardiovascular | Contract sterilization | Aug 12, 2015 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | Cardiovascular | Contract sterilization | May 14, 2013 |
| DWJ | System, Thermal Regulating | Class II | Cardiovascular | Contract sterilization | Jan 16, 2019 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract sterilization | May 13, 2026 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract sterilization | Feb 9, 2021 |
| EXR | Urinometer, Mechanical | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| EZD | Catheter, Straight | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract sterilization | Nov 15, 2012 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | Class I | Gastroenterology and urology | Contract sterilization | Aug 14, 2025 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| FDE | Laparoscopy Kit | Class II | Gastroenterology and urology | Contract sterilization | Jun 25, 2025 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| FKG | Tray, Start/Stop (Including Contents), Dialysis | Class I | Gastroenterology and urology | Contract sterilization | Apr 26, 2017 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FMJ | Manometer, Spinal-Fluid | Class II | General hospital | Contract sterilization | Jul 7, 2017 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class II | General hospital | Contract sterilization | Jul 7, 2017 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract sterilization | Dec 5, 2012 |
| FPD | Tube, Feeding | Class II | Gastroenterology and urology | Contract sterilization | Jul 25, 2013 |
| FPK | Tubing, Fluid Delivery | Class II | General hospital | Contract sterilization | Dec 5, 2012 |
| FRG | Wrap, Sterilization | Class II | General hospital | Contract sterilization | Jul 7, 2017 |
| FRN | Pump, Infusion | Class II | General hospital | Contract sterilization | Jun 27, 2023 |
| FTN | Plastic Surgery And Accessories Kit | Class I | General and plastic surgery | Contract sterilization | Aug 14, 2025 |
| FYA | Gown, Surgical | Class II | General and plastic surgery | Contract sterilization | Dec 4, 2012 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GAG | Stapler, Surgical | Class II | General hospital | Contract sterilization | Feb 25, 2025 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Nov 1, 2012 |
| GBM | Catheter, Urethral | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | May 14, 2013 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Jul 5, 2017 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class II | General hospital | Contract sterilization | Feb 4, 2013 |
| GDM | Needle, Aspiration And Injection, Reusable | Class I | General and plastic surgery | Contract sterilization | Mar 30, 2014 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract sterilization | Jul 5, 2017 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GEC | Brush, Scrub, Operating-Room | Class I | General and plastic surgery | Contract sterilization | May 14, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Aug 16, 2017 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Class II | Clinical chemistry | Contract sterilization | Jul 7, 2017 |
| GKT | Separator, Automated, Blood Cell, Diagnostic | Class II | Hematology | Contract sterilization | Nov 30, 2020 |
| HBI | Illuminator, Fiberoptic, Surgical Field | Class II | General and plastic surgery | Contract sterilization | Jul 7, 2017 |
| HED | Douche Apparatus, Vaginal, Therapeutic | Class I | Obstetrics and gynecology | Contract sterilization | May 14, 2013 |
| HGD | Applicator, Vaginal | Class I | Obstetrics and gynecology | Contract sterilization | Nov 30, 2012 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | Class I | Obstetrics and gynecology | Contract sterilization | Nov 20, 2012 |
| HNX | Depressor, Orbital | Class I | Ophthalmic | Contract sterilization | Apr 3, 2013 |
| HRX | Arthroscope | Class II | Orthopedic | Contract sterilization | Jul 11, 2013 |
| ILY | Lamp, Infrared, Therapeutic Heating | Class II | Physical medicine | Contract sterilization | May 14, 2013 |
| JOK | Scissors, Medical, Disposable | Class I | General hospital | Contract sterilization | May 14, 2013 |
| JOL | Catheter And Tip, Suction | Class II | General hospital | Contract sterilization | Jun 15, 2009 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | May 14, 2013 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | Class II | Gastroenterology and urology | Contract sterilization | Jul 7, 2017 |
| KGO | Surgeon'S Gloves | Class I | General and plastic surgery | Contract sterilization | Oct 24, 2012 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Feb 3, 2026 |
| KGZ | Accessories, Catheter | Class I | General and plastic surgery | Contract sterilization | Nov 28, 2012 |
| KKX | Drape, Surgical, Antimicrobial | Class II | General and plastic surgery | Contract sterilization | Dec 4, 2012 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Class II | Gastroenterology and urology | Contract sterilization | Nov 15, 2012 |
| KNY | Accessories, Catheter, G-U | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| KOD | Catheter, Urological | Class II | Gastroenterology and urology | Contract sterilization | May 14, 2013 |
| KSW | System, Processing For Frozen Blood | Class II | Hematology | Contract sterilization | Jun 27, 2023 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract sterilization | Apr 17, 2013 |
| LEC | Grinder, Tissue | Class I | Pathology | Contract sterilization | Jul 7, 2017 |
| LFL | Instrument, Ultrasonic Surgical | Unclassified | General and plastic surgery | Contract sterilization | Feb 2, 2021 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | Unclassified | Gastroenterology and urology | Contract sterilization | Jun 27, 2023 |
| LRO | General Surgery Tray | Class II | General and plastic surgery | Contract sterilization | Jul 7, 2017 |
| LRP | Tray, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 30, 2012 |
| LRS | I.V. Start Kit | Class II | General hospital | Contract sterilization | May 14, 2013 |
| LYV | Label Or Tag, Sterile | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| LYZ | Vinyl Patient Examination Glove | Class I | General hospital | Contract sterilization | May 14, 2013 |
| LZH | Pump, Infusion, Enteral | Class II | General hospital | Contract sterilization | Jul 7, 2017 |
| MLS | Labor And Delivery Kit | Class II | Obstetrics and gynecology | Contract sterilization | Apr 26, 2017 |
| MLT | Pelvic Exam Kit | Class II | Obstetrics and gynecology | Contract sterilization | Apr 26, 2017 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract sterilization | Jun 20, 2017 |
| NLF | Oximeter, Reprocessed | Class II | Cardiovascular | Contract sterilization | May 14, 2013 |
| NWT | Endoscopic Cholangiogram Kit | Class II | Gastroenterology and urology | Contract sterilization | Aug 14, 2025 |
| NWU | Endoscope Introducer Kit | Class II | Gastroenterology and urology | Contract sterilization | Aug 6, 2018 |
| OEQ | Angiography/Angioplasty Kit | Class II | Cardiovascular | Contract sterilization | Apr 26, 2017 |
| OES | Cardiac Catheterization Kit | Class II | Cardiovascular | Contract sterilization | Apr 26, 2017 |
| OEZ | Cardiovascular Procedure Kit | Class II | Cardiovascular | Contract sterilization | May 3, 2017 |
| OFF | Central Venous Catheter Tray | Class II | Cardiovascular | Contract sterilization | Apr 26, 2017 |
| OFG | Ct Biopsy Tray | Class II | Cardiovascular | Contract sterilization | Aug 14, 2025 |
| OFO | Airway Suction Kit | Class I | Anesthesiology | Contract sterilization | Aug 22, 2013 |
| OFQ | Anesthesia Kit | Class II | Anesthesiology | Contract sterilization | Aug 14, 2025 |
| OFX | General Purpose Dental Tray | Class I | Dental | Contract sterilization | Apr 26, 2017 |
| OFZ | Blood Specimen Collection Kit (Excludes Hiv Testing) | Class I | Anesthesiology | Contract sterilization | Apr 26, 2017 |
| OGE | Epidural Anesthesia Kit | Class II | Anesthesiology | Contract sterilization | Jul 30, 2019 |
| OGH | Laryngoscope Kit | Class I | Anesthesiology | Contract sterilization | Aug 14, 2025 |
| OGJ | Nerve Block Tray | Class II | Anesthesiology | Contract sterilization | Apr 26, 2017 |
| OGR | Ear, Nose, And Throat Surgical Tray | Class I | Ear, nose and throat | Contract sterilization | Aug 14, 2025 |
| OGS | Myringotomy Procedure Kit | Class II | Ear, nose and throat | Contract sterilization | Aug 14, 2025 |
| OHD | Gynecological Laparoscopic Kit | Class II | Obstetrics and gynecology | Contract sterilization | Aug 14, 2025 |
| OHG | Circumcision Tray | Class II | Obstetrics and gynecology | Contract sterilization | Apr 26, 2017 |
| OHH | Breast Pump Kit | Class II | Obstetrics and gynecology | Contract sterilization | Aug 14, 2025 |
| OHM | Cesarean Section Tray | Class II | Obstetrics and gynecology | Contract sterilization | Apr 26, 2017 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Class I | Pathology | Contract sterilization | Aug 14, 2025 |
| OII | Arthrogram Tray | Class II | Radiology | Contract sterilization | Aug 14, 2025 |
| OIP | Radiology-Diagnostic Kit | Class II | Radiology | Contract sterilization | Feb 6, 2014 |
| OJF | Hysterectomy Kit | Class II | Obstetrics and gynecology | Contract sterilization | Aug 14, 2025 |
| OJG | Neurological Tray | Class I | Neurology | Contract sterilization | Aug 14, 2025 |
| OJH | Orthopedic Tray | Class I | General and plastic surgery | Contract sterilization | Aug 14, 2025 |
| OJJ | Burn Kit Without Drug | Class I | General and plastic surgery | Contract sterilization | Apr 26, 2017 |
| OJK | Eye Tray | Class II | Ophthalmic | Contract sterilization | Apr 26, 2017 |
| OJU | Skin Prep Tray | Class I | General and plastic surgery | Contract sterilization | Aug 22, 2013 |
| OJV | Single Use Instrument Tray | Class I | General and plastic surgery | Contract sterilization | Jun 30, 2015 |
| OKE | Port Introducer Kit | Class II | General hospital | Contract sterilization | Aug 14, 2025 |
| OKV | Obstetrical Kit | Class II | Obstetrics and gynecology | Contract sterilization | Aug 14, 2025 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Aug 14, 2025 |
| OVN | Suture Kit | Class II | General and plastic surgery | Contract sterilization | Aug 23, 2013 |
| OXQ | Dressing Change Tray | Class I | General hospital | Contract sterilization | Apr 26, 2017 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Class II | Gastroenterology and urology | Contract sterilization | Dec 4, 2020 |
| PKF | D And C Tray | Not classified | Obstetrics and gynecology | Contract sterilization | Aug 14, 2025 |
| PSD | Laparoscopic Gastrostomy Kit | Class II | Gastroenterology and urology | Contract sterilization | Aug 14, 2025 |
| PUI | Drape, Surgical, Exempt | Class II | General and plastic surgery | Contract sterilization | Mar 2, 2018 |
| PXJ | Umbilical Catheter Insertion Tray | Class II | General hospital | Contract sterilization | Aug 14, 2025 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Class II | Clinical chemistry | Contract sterilization | Oct 22, 2024 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | Class II | Clinical chemistry | Contract sterilization | Aug 12, 2026 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | Class II | Clinical chemistry | Contract sterilization | Aug 12, 2026 |