Where does the data come from?

openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Sterigenics US LLC (contract sterilizer, Charlotte, NC): 16 new FDA device listings, incl. nail, fixation, bone

Q: How to monitor Sterigenics US LLC and peer contract sterilizer records

DeviceEstablishmentPulse lists new DeviceEstablishmentPulse records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) as they are published; a free weekly email digest and paid alerts follow North Carolina records like this one.

Sterigenics US LLC (Charlotte, North Carolina): 16 new FDA device listings, incl. nail, fixation, bone. Its amount of 16 is top-decile (96th percentile of 2,709 records). Dated 118 days ago, it serves as a historical benchmark. Score 80/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of 2026-11-04 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 16 · 96th percentile of 2,709 DeviceEstablishmentPulse records · 8.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 32 related NC DeviceEstablishmentPulse records and the 5-column CSV export.

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	Charlotte, NC, US
New listings	16
Devices	Nail, Fixation, Bone; Screw, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Knife, Surgical; Arthroscope; Intervertebral Fusion Device With Bone Graft, Lumbar; Staple, Fixation, Bone
Product codes	JDS, HWC, HSB, DXT, IZQ, KCT, EMF, HRX, MAX, JDR, OLO, OUR
Device classes	Class I, Class II
Medical specialties	Orthopedic, Cardiovascular, General Hospital, General, Plastic Surgery, Neurology
Brand names	DynaNail TTC; MEDRAD® Centargo Day Set (CENT-DS); DynaNail Hybrid; LUX Expandable Lumbar Interbody System; Xenix Medical Sacroiliac Fixation System
First new listing	2026-05-21
Latest new listing	2026-07-10
FDA registration number	1058584
Registration expires	2026-12-31
amount percentile	96th of 2,709 (median 2, 8.0x median)
Peer records CSV (33 NC records)	🔒 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: 2026-07-10
Data refreshed: 2026-11-04
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Top DeviceEstablishmentPulse records (NC first): Lightning X Products, Inc (manufacturer, Charlotte, NC) · Sterigenics U.S., LLC (contract sterilizer, Charlotte, NC) · Structure Medical, LLC. (contract manufacturer, Mooresville, · Emage Medical, LLC (other, Charlotte, NC) · Medical Action Industries, Inc. 306 (manufacturer, Arden, NC · 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, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Sterigenics US LLC and 33 North Carolina peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

North Carolina DeviceEstablishmentPulse records like this one: 33
Sterigenics US LLC's amount: 96th percentile of 2,709 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every North Carolina peer: $6,600 (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 US LLC in Charlotte, North Carolina?

Sterigenics US LLC (Charlotte, NC), a contract sterilizer, added 16 FDA device listings between 2026-05-21 and 2026-07-10.

How does Sterigenics US LLC compare to other North Carolina DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 16 is 8.0x the median of 2 across 2,709 records. It is 118 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 US LLC vs. top 3 peers

Organization	Location	Amount	Percentile	Record date
Sterigenics US LLC	Charlotte, NC	16	96th	2026-07-10
Isomedix Operations, Inc.	Minneapolis, MN	16	96th	2026-10-21
Isomedix Operations Inc.	Sandy, UT	13	95th	2026-10-15
Isomedix Operations Inc.	Spartanburg, SC	11	93rd	2026-10-19

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How to monitor Sterigenics US LLC and peer contract sterilizer records

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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.