Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, UT): 51 new FDA device listings, incl. system, ablation, microwave and accessories
Sterigenics U.S., LLC (Salt Lake City, Utah): 51 new FDA device listings, incl. system, ablation, microwave and accessories. Its amount of 51 is top-decile (99th percentile of 2,570 records). Dated 106 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 51 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 51.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 31 related UT DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 99th of 2,570 (median 1, 51.0x median) |
| Peer records CSV (32 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-21
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (UT first): Zigg Design LLC (contract manufacturer, Nibley, UT) · Bard Access Systems, Inc. (other, Salt Lake City, UT) · Isomedix Operations Inc. (contract sterilizer, Sandy, UT) · Merit Medical Systems, Inc. (manufacturer, South Jordan, UT) · Live Tulani, LLC (repackager or relabeler, Farmington, UT) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Sterigenics U.S., LLC and 32 Utah peers
- Utah DeviceEstablishmentPulse records like this one: 32
- Sterigenics U.S., LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Sterigenics U.S., LLC in Salt Lake City, Utah?
Sterigenics U.S., LLC (Salt Lake City, UT), a contract sterilizer, added 51 FDA device listings between 2026-07-09 and 2026-07-21.
How does Sterigenics U.S., LLC compare to other Utah DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 51 is 51.0x the median of 1 across 2,570 records. It is 106 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Sterigenics U.S., LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics U.S., LLC | Salt Lake City, UT | 51 | 99th | 2026-07-21 |
| Isomedix Operations Inc. | Whippany, NJ | 26 | 98th | 2026-09-28 |
| Isomedix Operations Inc. | S Plainfield, NJ | 16 | 96th | 2026-09-28 |
| Isomedix Operations Inc. | Sandy, UT | 13 | 95th | 2026-10-15 |
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DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Utah
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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.