Contract sterilizerSterigenics Radiation Technologies IN, Inc (Columbia City, IN)IndianaAnesthesiologyCardiovascularGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryOrthopedicRadiologyClass IClass IIUnclassifiedClass III
Sterigenics Radiation Technologies IN, Inc
Contract sterilizer ยท Columbia City, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009504230 (openFDA record; or search FDA's registration database)
- FEI number
- 3009504230
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 4394 East Park 30 Drive, Columbia City, IN 46725
- Contract listings
- 50 device listings, 37 product codes, first listed Oct 29, 2012
- 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 |
|---|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Class I | Anesthesiology | Contract sterilization | Nov 16, 2012 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract sterilization | Jun 29, 2016 |
| EZD | Catheter, Straight | Class II | Gastroenterology and urology | Contract sterilization | Sep 9, 2024 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract sterilization | Aug 13, 2021 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Sep 9, 2024 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Aug 13, 2021 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Jun 4, 2026 |
| JDZ | Mixer, Cement, For Clinical Use | Class I | Orthopedic | Contract sterilization | Oct 29, 2012 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Sep 17, 2024 |
| KIH | Dispenser, Cement | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| KMK | Device, Intravascular Catheter Securement | Class I | General hospital | Contract sterilization | May 7, 2013 |
| KOD | Catheter, Urological | Class II | Gastroenterology and urology | Contract sterilization | Sep 9, 2024 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Class II | Radiology | Contract sterilization | Jun 29, 2016 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Nov 1, 2012 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Aug 13, 2021 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract sterilization | Aug 13, 2021 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract sterilization | Jul 8, 2025 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract sterilization | Dec 19, 2012 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class III | Cardiovascular | Contract sterilization | Oct 7, 2015 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Aug 13, 2021 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract sterilization | Jun 4, 2026 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | Class II | General and plastic surgery | Contract sterilization | Sep 17, 2024 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | Class II | General and plastic surgery | Contract sterilization | Aug 13, 2021 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | Class II | General and plastic surgery | Contract sterilization | Sep 17, 2024 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | Class II | General and plastic surgery | Contract sterilization | Sep 17, 2024 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract sterilization | Jul 8, 2025 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | Cardiovascular | Contract sterilization | Sep 17, 2024 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Class III | Cardiovascular | Contract sterilization | Feb 9, 2024 |