# Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, UT): 51 new FDA device listings, incl. system, ablation, microwave and accessories

**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 | Salt Lake City, UT, US |
| New listings | 51 |
| Devices | System, Ablation, Microwave And Accessories; Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented); Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; System, Appendage Closure, Left Atrial; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Catheter, Percutaneous; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Product codes | NEY, HSH, MBH, PHX, JDB, LZO, NGV, HSN, DQY, JWJ, KRO, HRY, KWA, PAO, NTG |
| Device classes | Class I, Class II, Class III |
| Medical specialties | General, Plastic Surgery, Orthopedic, Cardiovascular |
| Brand names | Ximitry Probe Assembly- IB-XPA-1315, IB-XPA-1320, IB-XPA-1327; PMI® Custom Device; Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Hume; Temperature Sensor Probe (ABL-TP-1820) |
| First new listing | 2026-07-09 |
| Latest new listing | 2026-07-21 |
| FDA registration number | 1721676 |
| 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.