Contract sterilizerIsomedix Operations Inc. (Chester, NY)New YorkAnesthesiologyCardiovascularGeneral and plastic surgeryHematologyGeneral hospitalOrthopedicDentalNeurologyClinical chemistryGastroenterology and urologyClass IIUnclassifiedClass IClass III
Isomedix Operations Inc.
Contract sterilizer ยท Chester, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013820501 (openFDA record; or search FDA's registration database)
- FEI number
- 3013820501
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- STERIS Corporation (FDA owner/operator no. 9072619)
- Registered address
- 2 Nucifora Blvd, Chester, NY 10918
- Contract listings
- 32 device listings, 26 product codes, first listed Sep 8, 2017
- 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 | Mar 31, 2022 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract sterilization | Mar 30, 2022 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Mar 28, 2022 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Sep 18, 2025 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Mar 31, 2022 |
| GGY | Pipette, Diluting | Class I | Hematology | Contract sterilization | Oct 27, 2020 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Jan 31, 2020 |
| KKX | Drape, Surgical, Antimicrobial | Class II | General and plastic surgery | Contract sterilization | Mar 25, 2022 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Jan 25, 2024 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Sep 8, 2017 |
| NAC | Dressing, Wound, Hydrophilic | Class I | General and plastic surgery | Contract sterilization | Mar 30, 2022 |
| NAD | Dressing, Wound, Occlusive | Class I | General and plastic surgery | Contract sterilization | Aug 14, 2018 |
| NPK | Barrier, Synthetic, Intraoral | Class II | Dental | Contract sterilization | Nov 6, 2020 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | Contract sterilization | Sep 18, 2025 |
| NPM | Bone Grafting Material, Animal Source | Class II | Dental | Contract sterilization | Mar 30, 2022 |
| NQR | Sealant, Dural | Class III | Neurology | Contract sterilization | Sep 18, 2017 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | Class II | General and plastic surgery | Contract sterilization | Sep 18, 2025 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract sterilization | Aug 19, 2024 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | Class II | Clinical chemistry | Contract sterilization | Feb 14, 2024 |
| QGA | Penile Implant Surgical Accessories | Class I | Gastroenterology and urology | Contract sterilization | Nov 16, 2022 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | Class II | Orthopedic | Contract sterilization | Jan 17, 2022 |