# Isomedix Operations Inc. (contract sterilizer, S Plainfield, NJ): 16 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue

**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 | S Plainfield, NJ, US |
| New listings | 16 |
| Devices | Fastener, Fixation, Nondegradable, Soft Tissue; Sealant, Microbial; Device, Impotence, Mechanical/Hydraulic; Joint, Knee, External Brace; Tissue Adhesive For The Topical Approximation Of Skin; Catheter, Septostomy; Snare, Flexible; Wire, Guide, Catheter; Cannula, Catheter; Trocar |
| Product codes | MBI, NZP, FHW, ITQ, MPN, DXF, FDI, DQX, DQR, DRC, DYB, OQG, LZO, MEH, LPH |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Orthopedic, General, Plastic Surgery, Gastroenterology, Urology, Physical Medicine, Cardiovascular |
| Brand names | US_Endoscopy4223 (PL) - Roth Net retriever select; US_Endoscopy4223 (PL) - Roth Net retriever - 360; Navilyst5285 (PL) - Micro Access Kit; Conformis6082 (PL) - Velora Hip System |
| First new listing | 2026-06-26 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 2246552 |
| 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.