Contract sterilizerSterigenics U.S., LLC (Tustin, CA)CaliforniaAnesthesiologyCardiovascularDentalGeneral hospitalPathologyGeneral and plastic surgeryGastroenterology and urologyNeurologyOphthalmicOrthopedicRadiologyMicrobiologyClinical chemistryClass IClass IIUnclassifiedClass III
Sterigenics U.S., LLC
Contract sterilizer ยท Tustin, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2022435 (openFDA record; or search FDA's registration database)
- FEI number
- 2022435
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 1401 Morgan Cir, Tustin, CA 92780
- Contract listings
- 91 device listings, 45 product codes, first listed May 13, 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 |
|---|---|---|---|---|---|
| BTQ | Airway, Nasopharyngeal | Class I | Anesthesiology | Contract sterilization | Nov 20, 2012 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract sterilization | Jul 6, 2026 |
| DRC | Trocar | Class II | Cardiovascular | Contract sterilization | Aug 12, 2015 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract sterilization | Jun 23, 2021 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract sterilization | Jun 19, 2017 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract sterilization | Feb 26, 2013 |
| FMF | Syringe, Piston | Class II | General hospital | Contract sterilization | Oct 24, 2012 |
| FMG | Stopcock, I.V. Set | Class II | General hospital | Contract sterilization | Feb 26, 2013 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Feb 26, 2013 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract sterilization | Oct 30, 2012 |
| FZP | Clip, Implantable | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2013 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Jul 5, 2017 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract sterilization | Jul 5, 2017 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Feb 26, 2013 |
| HAB | Saw, Powered, And Accessories | Class I | General and plastic surgery | Contract sterilization | Feb 27, 2013 |
| HCG | Device, Neurovascular Embolization | Class II | Neurology | Contract sterilization | Feb 26, 2013 |
| HOZ | Sponge, Ophthalmic | Class II | Ophthalmic | Contract sterilization | Feb 26, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract sterilization | Feb 26, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jun 22, 2021 |
| HWT | Template | Class I | Orthopedic | Contract sterilization | Jul 17, 2013 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Class II | Radiology | Contract sterilization | Feb 26, 2013 |
| JXA | Kit, Screening, Urine | Class I | Microbiology | Contract sterilization | Feb 27, 2013 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | May 13, 2009 |
| KKX | Drape, Surgical, Antimicrobial | Class II | General and plastic surgery | Contract sterilization | Feb 25, 2016 |
| KMJ | Lubricant, Patient | Class I | General hospital | Contract sterilization | Oct 30, 2012 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Feb 26, 2013 |
| KNY | Accessories, Catheter, G-U | Class II | Gastroenterology and urology | Contract sterilization | Oct 30, 2012 |
| KRA | Catheter, Continuous Flush | Class II | Cardiovascular | Contract sterilization | Aug 15, 2019 |
| KYF | Implant, Eye Valve | Class II | Ophthalmic | Contract sterilization | Jan 18, 2017 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Feb 26, 2013 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract sterilization | Nov 1, 2012 |
| MGB | Device, Hemostasis, Vascular | Class III | Cardiovascular | Contract sterilization | Jan 30, 2014 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Mar 5, 2018 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract sterilization | Jul 5, 2017 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract sterilization | Feb 27, 2013 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract sterilization | Feb 26, 2013 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | Contract sterilization | Feb 26, 2013 |
| OGO | Intraocular Pressure Lowering Implant | Class III | Ophthalmic | Contract sterilization | Feb 26, 2013 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General and plastic surgery | Contract sterilization | Oct 30, 2012 |
| PGN | Growing Rod System- Magnetic Actuation | Class II | Orthopedic | Contract sterilization | Jun 22, 2021 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Class II | Cardiovascular | Contract sterilization | Aug 15, 2019 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Class II | Clinical chemistry | Contract sterilization | Jul 6, 2026 |