Contract sterilizerSterigenics U.S., LLC (Schaumburg, IL)IllinoisAnesthesiologyCardiovascularGeneral hospitalGeneral and plastic surgeryGastroenterology and urologyOrthopedicDentalHematologyClass IIUnclassifiedClass I
Sterigenics U.S., LLC
Contract sterilizer · Schaumburg, IL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1420032 (openFDA record; or search FDA's registration database)
- FEI number
- 1420032
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 711 Cooper Ct, Schaumburg, IL 60173
- Contract listings
- 50 device listings, 29 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 |
|---|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | Contract sterilization | Jun 6, 2013 |
| CAF | Nebulizer (Direct Patient Interface) | Class II | Anesthesiology | Contract sterilization | Jun 6, 2013 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Jan 18, 2022 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Mar 20, 2024 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Nov 28, 2012 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| FTA | Light, Surgical, Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract sterilization | Nov 1, 2012 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Oct 29, 2012 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Jun 6, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 14, 2012 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract sterilization | Apr 12, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Mar 15, 2018 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract sterilization | May 3, 2013 |
| JEY | Plate, Bone | Class II | Dental | Contract sterilization | Jun 6, 2013 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology and urology | Contract sterilization | Oct 18, 2019 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| KQZ | Component, Traction, Non-Invasive | Class I | Orthopedic | Contract sterilization | Nov 15, 2012 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract sterilization | Dec 11, 2024 |
| LYV | Label Or Tag, Sterile | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Mar 15, 2018 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | Class II | Gastroenterology and urology | Contract sterilization | Oct 18, 2019 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Feb 3, 2022 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | Class II | Gastroenterology and urology | Contract sterilization | Nov 14, 2012 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract sterilization | Nov 5, 2020 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract sterilization | Dec 11, 2024 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Jun 9, 2021 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | Class II | General hospital | Contract sterilization | May 20, 2025 |