Contract sterilizerSterigenics U.S., LLC (Salem, NJ)New JerseyCardiovascularDentalPathologyGeneral and plastic surgeryOphthalmicPhysical medicineGeneral hospitalClass IIClass IUnclassified
Sterigenics U.S., LLC
Contract sterilizer · Salem, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2245590 (openFDA record; or search FDA's registration database)
- FEI number
- 2245590
- Registered for
- FDA registration year 2026
- Establishment types
- Contract sterilizer
- Owner or operator
- Sotera Health LLC (FDA owner/operator no. 10029425)
- Registered address
- 75 Tilbury Rd, Salem, NJ 08079
- Contract listings
- 32 device listings, 19 product codes, first listed Jun 11, 2010
- 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 |
|---|---|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract sterilization | Nov 13, 2012 |
| DZA | Drill, Dental, Intraoral | Class I | Dental | Contract sterilization | Jul 11, 2017 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract sterilization | Aug 31, 2018 |
| DZM | Needle, Dental | Class I | Dental | Contract sterilization | Nov 13, 2012 |
| DZP | Instrument, Diamond, Dental | Class I | Dental | Contract sterilization | Nov 8, 2012 |
| EKS | File, Pulp Canal, Endodontic | Class I | Dental | Contract sterilization | Jul 2, 2019 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Jun 11, 2010 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Oct 31, 2012 |
| GAO | Suture, Nonabsorbable | Class II | General and plastic surgery | Contract sterilization | Nov 13, 2012 |
| 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 13, 2012 |
| HPZ | Implant, Eye Sphere | Class II | Ophthalmic | Contract sterilization | Apr 29, 2021 |
| HQN | Conformer, Ophthalmic | Class II | Ophthalmic | Contract sterilization | Apr 29, 2021 |
| IKD | Cable, Electrode | Class II | Physical medicine | Contract sterilization | Nov 12, 2012 |
| KJJ | Cleanser, Root Canal | Unclassified | Dental | Contract sterilization | Jul 2, 2019 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Nov 13, 2012 |
| LRY | Punch, Surgical | Class I | General and plastic surgery | Contract sterilization | Oct 24, 2012 |
| 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 |