# Isomedix Operations Inc. (contract sterilizer, San Diego, CA): 4 new FDA device listings, incl. septostomy catheter, reprocessed

**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 | San Diego, CA, US |
| New listings | 4 |
| Devices | Septostomy Catheter, Reprocessed; Device, Monitoring, Intracranial Pressure; Reprocessed Catheter Introducer |
| Product codes | QLZ, GWM, PNE |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Neurology |
| Brand names | Innovative7777 (SDA) - Reprocessed NRG Transseptal Needle; Innovative7777 (SDA) - Septostomy Catheter, Reprocessed; Medtronic4423 (SDA) - Exacta; Innovative7777 (SDA) - Reprocessed Steerable Introducer |
| First new listing | 2026-09-17 |
| Latest new listing | 2026-10-23 |
| FDA registration number | 2032112 |
| 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.