# Sterigenics U.S., LLC (contract sterilizer, Charlotte, NC): 15 new FDA device listings, incl. radioimmunoassay, thyroid-stimulating hormone

**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 | Charlotte, NC, US |
| New listings | 15 |
| Devices | Radioimmunoassay, Thyroid-Stimulating Hormone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Cutaneous Tissue Adhesive With Mesh; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; System, Cement Removal Extraction; Arthroscope; Burr, Orthopedic; Mesh, Surgical, Polymeric; Screw, Fixation, Bone |
| Product codes | JLW, HWE, OMD, OTO, LZV, HRX, HTT, FTL, HWC |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, General, Plastic Surgery, Orthopedic |
| Brand names | MICRO OSCBLD COARS 5.5X12X0.4MM ST 5 EA; 3M OSCILLATOR SAW BLADE REPLACEMENT, ME-92 COATED 19.5 X 80 X 9MM, 5 EA; 3M OSCILLATOR SAW BLADE REPLACEMENT 19.5 X 86X 1.27MM, 5 EA; MAXI DRVR OSC BLD 10X85X1.27,1.27MM 5 EA; 19.5 X 86 X 1.27MM 3M OSCILLATOR SAW BLADE REPLACEMENT, COATED, 5 EA; ST PILOT DRILL SHT 1 X 10MM; ST PILOT DRL DENTAL 1.5 X 15MM; ST PILOT DRILL SHT 1 X 15MM |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1061124 |
| 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.