# Sterigenics U.S., LLC (contract sterilizer, Tustin, CA): 7 new FDA device listings, incl. injector and syringe, angiographic

**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 | Tustin, CA, US |
| New listings | 7 |
| Devices | Injector And Syringe, Angiographic; Abutment, Implant, Dental, Endosseous; Set, I.V. Fluid Transfer; Negative Pressure Wound Therapy Powered Suction Pump; Mesh, Surgical, Polymeric; Wire, Guide, Catheter; Alternate Controller Enabled Insulin Infusion Pump |
| Product codes | DXT, NHA, LHI, OMP, FTL, DQX, QFG |
| Device classes | Class II |
| Medical specialties | Cardiovascular, Dental, General Hospital, General, Plastic Surgery, Clinical Chemistry |
| Brand names | 6408490 / 800923-008 A1000V; 6405286 / 801060-003 A1000; 6411585 / 801061-005 BT2000; 6419886 / 800923-010 A1000V; Inclusive Multi-Unit Abutment 1 mmH compatible with: Straumann Tissue Level RN synOcta; Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Tissue Level WN synOcta; HYHUB™ Vial Access Devices; SureAx-GUIDE |
| First new listing | 2026-06-24 |
| Latest new listing | 2026-07-06 |
| FDA registration number | 2022435 |
| 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.