Contract sterilizerSterigenics U.S., LLC (Rockaway, NJ)New JerseyAnesthesiologyCardiovascularDentalGeneral hospitalGeneral and plastic surgeryGastroenterology and urologyOphthalmicHematologyNeurologyObstetrics and gynecologyClinical chemistryOrthopedicClass IIClass IClass III
Sterigenics U.S., LLC
Contract sterilizer ยท Rockaway, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2219920 (openFDA record; or search FDA's registration database)
- FEI number
- 2219920
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 108 Lake Denmark Rd, Rockaway, NJ 07866
- Contract listings
- 51 device listings, 26 product codes, first listed Oct 30, 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 |
|---|---|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | Class II | Anesthesiology | Contract sterilization | Nov 20, 2012 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract sterilization | Aug 29, 2014 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Nov 29, 2012 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract sterilization | Aug 31, 2018 |
| EJK | Liner, Cavity, Calcium Hydroxide | Class II | Dental | Contract sterilization | Nov 29, 2012 |
| FQZ | Thermometer, Clinical Color Change | Class I | General hospital | Contract sterilization | Mar 26, 2014 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract sterilization | Nov 29, 2012 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Feb 21, 2013 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Oct 30, 2012 |
| HKY | Tonometer, Manual | Class II | Ophthalmic | Contract sterilization | Nov 29, 2012 |
| HOC | Clip, Iris Retractor | Class I | Ophthalmic | Contract sterilization | Nov 8, 2012 |
| JOH | Tube Tracheostomy And Tube Cuff | Class II | Anesthesiology | Contract sterilization | Nov 20, 2012 |
| JOS | Electrode, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Aug 27, 2013 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Nov 1, 2012 |
| LXA | Tissue Graft Of 6mm And Greater | Class III | Cardiovascular | Contract sterilization | Aug 31, 2018 |
| LYC | Bone Grafting Material, Synthetic | Class II | Dental | Contract sterilization | Nov 29, 2012 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract sterilization | Aug 8, 2023 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract sterilization | Aug 31, 2018 |
| NPM | Bone Grafting Material, Animal Source | Class II | Dental | Contract sterilization | Aug 31, 2018 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract sterilization | Jul 11, 2023 |
| OTJ | Laparoscopic Single Port Access Device | Class II | Gastroenterology and urology | Contract sterilization | Feb 21, 2013 |
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port | Class II | Obstetrics and gynecology | Contract sterilization | Aug 31, 2018 |
| PNL | Magnetic Surgical System | Class II | General and plastic surgery | Contract sterilization | May 7, 2026 |
| PRJ | Capillary Blood Collection Device For Alternative Site Collection | Class II | Clinical chemistry | Contract sterilization | Aug 31, 2018 |
| QES | Reherniation Reduction Device | Class III | Orthopedic | Contract sterilization | Apr 16, 2019 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | Class II | General hospital | Contract sterilization | May 20, 2025 |