# Sterigenics US LLC (contract sterilizer, Grand Prairie, TX): 15 new FDA device listings, incl. tape and bandage, adhesive

**Score:** 80/100

| 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 | Grand Prairie, TX, US |
| New listings | 15 |
| Devices | Tape And Bandage, Adhesive; Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Catheter, Ureteral, Gastro-Urology; Powered Laser Surgical Instrument; Accessories, Blood Circuit, Hemodialysis; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Subsystem, Water Purification; Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Product codes | KGX, QBJ, SAF, SBH, EYB, GEX, KOC, FJK, FIP, KDI, NII, KNS, FFY |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Clinical Chemistry, Gastroenterology, Urology, General, Plastic Surgery |
| Brand names | Stelo Biosensor System; Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System; 5008X Hemodialysis System |
| First new listing | 2026-05-29 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 3004111573 |
| 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.