# Sterigenics U.S., LLC (contract sterilizer, Ontario, CA): 7 new FDA device listings, incl. integrated continuous glucose monitoring system, factory calibrated

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Ontario, CA, US |
| New listings | 7 |
| Devices | Integrated Continuous Glucose Monitoring System, Factory Calibrated; Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Introducer, Catheter |
| Product codes | QBJ, KGX, SAF, SBH, DYB |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, General Hospital, Cardiovascular |
| Brand names | Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System; Stelo Biosensor System |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 2029015 |
| 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.

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.