# Sterigenics US LLC (contract sterilizer, Los Angeles, CA): 8 new FDA device listings, incl. device, surgical, cryogenic

**Score:** 90/100

| Field | Value |
|---|---|
| Establishment | Sterigenics US LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Los Angeles, CA, US |
| New listings | 8 |
| Devices | Device, Surgical, Cryogenic; Stimulator, Nerve; Device, Monitoring, Intracranial Pressure; Catheter, Continuous Flush |
| Product codes | GXH, ETN, GWM, KRA |
| Device classes | Class II |
| Medical specialties | Neurology, Ear, Nose, Throat, Cardiovascular |
| Brand names | Exacta™; Echelon - 14 Tip ShapeMicro Catheter; Echelon - 10 Tip ShapeMicro Catheter; Tip Shape Echelon Micro Catheter; Echelon - 14 Micro Catheter; Echelon Micro Catheter; Rebar MicroCatheter; Echelon - 10 Micro Catheter |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 2011171 |
| Registration expires | 2026-12-31 |

## 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.