# Sterigenics US LLC (contract sterilizer, Gurnee, IL): 19 new FDA device listings, incl. lipoaspirate washing system for aesthetic body contouring

**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 | Gurnee, IL, US |
| New listings | 19 |
| Devices | Lipoaspirate Washing System For Aesthetic Body Contouring; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; System, Suction, Lipoplasty; Saline, Vascular Access Flush; Powered Microneedle Device; Adaptor, Holder, Syringe |
| Product codes | QKL, PHX, KWS, KWT, MBF, HSD, MUU, NGT, QAI, IQG, OIY, MBH, JWH, SCN |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic, General Hospital, Physical Medicine, Neurology |
| Brand names | Puregraft 250 system; Comprehensive Reverse Shoulder - HA Glenosphere Baseplates; Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Hume; Cytrellis Dermal Micro-Coring System; Celling Application Kit; Zimmer Persona Personalized Knee System; Puregraft 50 system; SPRINT Peripheral Nerve Stimulation (PNS) System |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-07-09 |
| FDA registration number | 1423662 |
| 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.