Sterigenics US LLC (contract sterilizer, Grand Prairie, TX): 15 new FDA device listings, incl. tape and bandage, adhesive

Sterigenics US LLC (Grand Prairie, Texas): 15 new FDA device listings, incl. tape and bandage, adhesive. Its amount of 15 is top-decile (96th percentile of 2,570 records). Dated 84 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: 15 · 96th percentile of 2,570 DeviceEstablishmentPulse records · 15.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 67 related TX DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSterigenics US LLC
Owner / operatorSotera Health LLC
RoleContract sterilizer
Establishment typesSterilize Medical Device for Another Party (Contract Sterilizer)
LocationGrand Prairie, TX, US
New listings15
DevicesTape And Bandage, Adhesive; Integrated Continuous Glucose Monitoring System, Factory Calibrated; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter; Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter; Catheter, Ureteral, Gastro-Urology; Powered Laser Surgical Instrument; Accessories, Blood Circuit, Hemodialysis; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Subsystem, Water Purification; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product codesKGX, QBJ, SAF, SBH, EYB, GEX, KOC, FJK, FIP, KDI, NII, KNS, FFY
Device classesClass I, Class II
Medical specialtiesGeneral Hospital, Clinical Chemistry, Gastroenterology, Urology, General, Plastic Surgery
Brand namesStelo Biosensor System; Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System; 5008X Hemodialysis System
First new listing2026-05-29
Latest new listing2026-08-12
FDA registration number3004111573
Registration expires2026-12-31
amount percentile96th of 2,570 (median 1, 15.0x median)
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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: 2026-08-12
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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Top DeviceEstablishmentPulse records (TX first): Sterigenics US LLC (contract sterilizer, Fort Worth, TX) · Midwest Sterilization Corp. (contract sterilizer, Laredo, TX · Mlife Diagnostics LLC (contract manufacturer, Marshall, TX) · Gramercy Extremity Orthopedics, LLC. (manufacturer, Richards · Inspiration Medical Technology, Inc. (repackager or relabele · 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 US LLC and 68 Texas peers

  • Texas DeviceEstablishmentPulse records like this one: 68
  • Sterigenics US LLC's amount: 96th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Texas peer: $13,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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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 Grand Prairie, Texas?

Sterigenics US LLC (Grand Prairie, TX), a contract sterilizer, added 15 FDA device listings between 2026-05-29 and 2026-08-12.

How does Sterigenics US LLC compare to other Texas DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 15 is 15.0x the median of 1 across 2,570 records. It is 84 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

OrganizationLocationAmountPercentileRecord date
Sterigenics US LLCGrand Prairie, TX1596th2026-08-12
Isomedix Operations Inc.S Plainfield, NJ1696th2026-09-28
Isomedix Operations Inc.Sandy, UT1395th2026-10-15
Isomedix Operations, Inc.Minneapolis, MN1295th2026-10-14

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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

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.

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