Contract sterilizerISOMEDIX OPERATIONS INC. (Chester, NY)New YorkGeneral hospitalCardiovascularDentalGeneral and plastic surgeryGastroenterology and urologyPathologyNeurologyOphthalmicOrthopedicRadiologyEar, nose and throatHematologyObstetrics and gynecologyClass IIClass IUnclassifiedClass III
ISOMEDIX OPERATIONS INC.
Contract sterilizer ยท Chester, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1319660 (openFDA record; or search FDA's registration database)
- FEI number
- 1000136478
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract sterilizer
- Owner or operator
- STERIS Corporation (FDA owner/operator no. 1527821)
- Registered address
- 23 ELIZABETH DR., Chester, NY 10918
- Contract listings
- 161 device listings, 112 product codes, first listed Dec 2, 1992
- 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 |
|---|---|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | Class II | General hospital | Contract sterilization | Nov 15, 2012 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract sterilization | Sep 8, 2025 |
| DSK | Computer, Blood-Pressure | Class II | Cardiovascular | Contract sterilization | Sep 8, 2025 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract sterilization | Dec 27, 2012 |
| DXC | Clamp, Vascular | Class II | Cardiovascular | Contract sterilization | Dec 17, 2012 |
| DZP | Instrument, Diamond, Dental | Class I | Dental | Contract sterilization | Jan 18, 2023 |
| EFQ | Gauze/Sponge, Internal | Unclassified | General and plastic surgery | Contract sterilization | Jul 31, 2024 |
| EHL | Point, Abrasive | Class I | Dental | Contract sterilization | Jan 18, 2023 |
| EJL | Bur, Dental | Class I | Dental | Contract sterilization | Dec 28, 2012 |
| EKS | File, Pulp Canal, Endodontic | Class I | Dental | Contract sterilization | Oct 7, 2020 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Class II | Gastroenterology and urology | Contract sterilization | Jan 7, 2013 |
| FHX | Jelly, Lubricating, For Transurethral Surgical Instrument | Class II | Gastroenterology and urology | Contract sterilization | Mar 14, 2014 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract sterilization | Nov 14, 2012 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract sterilization | Jan 4, 2018 |
| FQH | Lavage, Jet | Class II | General hospital | Contract sterilization | Jan 8, 2013 |
| FRL | Fiber, Medical, Absorbent | Class I | General hospital | Contract sterilization | Dec 28, 2012 |
| FRN | Pump, Infusion | Class II | General hospital | Contract sterilization | Jan 4, 2018 |
| FRO | Dressing, Wound, Drug | Unclassified | General and plastic surgery | Contract sterilization | Jan 8, 2013 |
| FTM | Mesh, Surgical | Class II | General and plastic surgery | Contract sterilization | Nov 16, 2012 |
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract sterilization | Dec 27, 2012 |
| FZZ | Marker, Skin | Class I | General and plastic surgery | Contract sterilization | Apr 11, 1994 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract sterilization | Nov 7, 2012 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract sterilization | Dec 20, 2012 |
| GAX | Tourniquet, Nonpneumatic | Class I | General and plastic surgery | Contract sterilization | Nov 7, 2012 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract sterilization | Nov 15, 2012 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | Class I | General and plastic surgery | Contract sterilization | Dec 27, 2012 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract sterilization | Nov 9, 2012 |
| GEN | Forceps, General & Plastic Surgery | Class I | General and plastic surgery | Contract sterilization | Nov 9, 2012 |
| GEY | Motor, Surgical Instrument, Ac-Powered | Class I | General and plastic surgery | Contract sterilization | Jan 30, 2013 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract sterilization | Nov 9, 2012 |
| GXQ | Dura Substitute | Class II | Neurology | Contract sterilization | Nov 16, 2012 |
| GXZ | Electrode, Needle | Class II | Neurology | Contract sterilization | Nov 9, 2012 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Class II | Neurology | Contract sterilization | Nov 7, 2012 |
| HAM | Apparatus, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Nov 9, 2012 |
| HBA | Neurosurgical Paddie | Class II | Neurology | Contract sterilization | Mar 26, 2013 |
| HCF | Instrument, Ligature Passing And Knot Tying | Class I | General and plastic surgery | Contract sterilization | Feb 22, 2018 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Dec 27, 2012 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Nov 26, 2012 |
| HNY | Cystotome | Class I | Ophthalmic | Contract sterilization | Dec 27, 2012 |
| HOZ | Sponge, Ophthalmic | Class II | Ophthalmic | Contract sterilization | Jun 28, 2015 |
| HQC | Unit, Phacofragmentation | Class II | Ophthalmic | Contract sterilization | Nov 26, 2012 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | Class II | Ophthalmic | Contract sterilization | Nov 9, 2012 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Class II | Ophthalmic | Contract sterilization | Nov 26, 2012 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Oct 27, 2022 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jul 8, 2022 |
| HTS | Knife, Orthopedic | Class I | Orthopedic | Contract sterilization | Jan 7, 2013 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract sterilization | Jan 23, 2020 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Oct 27, 2022 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract sterilization | Sep 8, 2025 |
| IWP | Radiographic Protective Glove | Class I | Radiology | Contract sterilization | Jan 29, 2020 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Class II | Radiology | Contract sterilization | Oct 18, 2012 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract sterilization | Aug 30, 2023 |
| JOS | Electrode, Electrosurgical | Class II | General and plastic surgery | Contract sterilization | Nov 9, 2012 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Feb 18, 2020 |
| JXI | Cuff, Nerve | Class II | Neurology | Contract sterilization | Nov 16, 2012 |
| KCN | Ear Wick | Class I | Ear, nose and throat | Contract sterilization | Dec 27, 2012 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology and urology | Contract sterilization | Mar 20, 2024 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | General and plastic surgery | Contract sterilization | Dec 18, 2012 |
| KGX | Tape And Bandage, Adhesive | Class I | General hospital | Contract sterilization | Nov 16, 2012 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract sterilization | Dec 18, 2013 |
| KJA | Flask, Tissue Culture | Class I | Hematology | Contract sterilization | Dec 28, 2012 |
| KJC | Bottle, Roller, Tissue Culture | Class I | Hematology | Contract sterilization | Dec 18, 2013 |
| KJD | Spinner, Flask | Class I | Hematology | Contract sterilization | Mar 29, 2023 |
| KJE | Spinner System, Cell Culture | Class I | Hematology | Contract sterilization | Dec 18, 2013 |
| KJF | System, Suspension, Cell Culture | Class I | Hematology | Contract sterilization | Dec 18, 2013 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract sterilization | Oct 9, 2012 |
| KYF | Implant, Eye Valve | Class II | Ophthalmic | Contract sterilization | Dec 14, 2020 |
| LEC | Grinder, Tissue | Class I | Pathology | Contract sterilization | Mar 14, 2014 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract sterilization | Oct 18, 2021 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract sterilization | Oct 31, 2012 |
| LYA | Splint, Intranasal Septal | Class I | Ear, nose and throat | Contract sterilization | Jan 30, 2013 |
| LYC | Bone Grafting Material, Synthetic | Class II | Dental | Contract sterilization | Nov 16, 2012 |
| LZU | Plug, Punctum | Unclassified | Ophthalmic | Contract sterilization | Jun 28, 2015 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Jan 23, 2020 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract sterilization | Oct 27, 2022 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract sterilization | Jan 31, 2024 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract sterilization | Mar 3, 2014 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class II | Orthopedic | Contract sterilization | Dec 19, 2012 |
| MEA | Pump, Infusion, Pca | Class II | General hospital | Contract sterilization | May 23, 2022 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract sterilization | Nov 25, 2025 |
| MLZ | Vitrectomy, Instrument Cutter | Class II | Ophthalmic | Contract sterilization | Nov 26, 2012 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract sterilization | Dec 3, 2024 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract sterilization | Dec 3, 2024 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | Class II | Obstetrics and gynecology | Contract sterilization | Sep 9, 2024 |
| MQV | Filler, Bone Void, Calcium Compound | Class II | Orthopedic | Contract sterilization | Nov 16, 2012 |
| MWS | Stabilizer, Heart | Class I | Cardiovascular | Contract sterilization | Dec 27, 2012 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Class I | Ophthalmic | Contract sterilization | Dec 27, 2012 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | Class I | General and plastic surgery | Contract sterilization | Dec 2, 1992 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class I | General and plastic surgery | Contract sterilization | Dec 28, 2012 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract sterilization | Sep 27, 2019 |
| NGY | Cannula, Trocar, Ophthalmic | Class I | Ophthalmic | Contract sterilization | Dec 27, 2012 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | Class II | Neurology | Contract sterilization | Nov 7, 2012 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract sterilization | Dec 3, 2024 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | Contract sterilization | Nov 16, 2012 |
| NPM | Bone Grafting Material, Animal Source | Class II | Dental | Contract sterilization | Nov 16, 2012 |
| NUN | Bone Grafting Material, Human Source | Class II | Dental | Contract sterilization | Oct 28, 2013 |
| OCW | Endoscopic Tissue Approximation Device | Class II | Gastroenterology and urology | Contract sterilization | Jan 7, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract sterilization | Oct 27, 2022 |
| OGO | Intraocular Pressure Lowering Implant | Class III | Ophthalmic | Contract sterilization | Oct 17, 2024 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract sterilization | Jul 8, 2022 |
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | Class II | General and plastic surgery | Contract sterilization | Feb 10, 2023 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract sterilization | Oct 10, 2019 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract sterilization | Nov 11, 2015 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract sterilization | Dec 5, 2024 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | Class II | General and plastic surgery | Contract sterilization | Dec 10, 2025 |
| PDQ | Neurosurgical Nerve Locator | Class II | Ear, nose and throat | Contract sterilization | Oct 10, 2019 |
| PHC | Infusion Safety Management Software | Class II | General hospital | Contract sterilization | Jan 4, 2018 |
| PKP | Immunoglobulin G (Igg) Infusion System | Class II | General hospital | Contract sterilization | Sep 12, 2024 |
| PLF | Bone Wedge | Class II | Orthopedic | Contract sterilization | Oct 27, 2022 |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Class II | Obstetrics and gynecology | Contract sterilization | Aug 2, 2022 |
| QGA | Penile Implant Surgical Accessories | Class I | Gastroenterology and urology | Contract sterilization | May 12, 2025 |
| QWK | Prosthesis, Posterior Spinal Elements | Class III | Orthopedic | Contract sterilization | Dec 3, 2024 |