# Isomedix Operations Inc. (contract sterilizer, Spartanburg, SC): 11 new FDA device listings, incl. set, i.v. fluid transfer

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Isomedix Operations Inc. |
| Owner / operator | STERIS Corporation |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only |
| Location | Spartanburg, SC, US |
| New listings | 11 |
| Devices | Set, I.V. Fluid Transfer; Pump, Infusion; Stand, Infusion; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Snare, Flexible; Catheter, Septostomy; Pump, Infusion, Insulin Bolus; Pump, Infusion, Insulin |
| Product codes | LHI, FRN, FOX, HBE, HBG, JWH, FDI, DXF, OPP, LZG |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Neurology, Orthopedic, Gastroenterology, Urology, Cardiovascular |
| Brand names | AdvancedConcept8660 (SP) - Freedom Total Knee System – Titanium Tibial Base Plate*; AdvancedConcept8660 (SP) - Freedom – TiNbN Coated Knee; US_Endoscopy4223 (SP) - Roth Net retriever - 360; US_Endoscopy4223 (SP) - Roth Net retriever select |
| First new listing | 2026-05-28 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 1047843 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.