# Isomedix Operations, Inc. (contract sterilizer, Temecula, CA): 7 new FDA device listings, incl. percutaneous catheter, ultrasound

**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) |
| Location | Temecula, CA, US |
| New listings | 7 |
| Devices | Percutaneous Catheter, Ultrasound; Catheter, Retention Type, Balloon; Stylet, Catheter; Catheter, Electrode Recording, Or Probe, Electrode Recording; Stimulator, Spinal-Cord, Implanted (Pain Relief); Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Product codes | PPN, EZL, DRB, DRF, GZB, LGW, QRB |
| Device classes | Class II, Class III |
| Medical specialties | Cardiovascular, Gastroenterology, Urology, Neurology |
| Brand names | Merit1383 (TM) - Bulldog Lead Extender |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 2030624 |
| 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: 2026-10-28T20:51:27.468Z.
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.