Sterigenics U.S., LLC (contract sterilizer, Rockaway, NJ): 2 new FDA device listings, incl. implant, endosseous, root-form
Sterigenics U.S., LLC (Rockaway, New Jersey): 2 new FDA device listings, incl. implant, endosseous, root-form. Its amount of 2 is above the median of 1 (69th percentile). Dated 106 days ago, it serves as a historical benchmark. Score 65/100. 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 48 related NJ 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 | Rockaway, NJ, US |
| New listings | 2 |
| Devices | Implant, Endosseous, Root-Form; Magnetic Surgical System |
| Product codes | DZE, PNL |
| Device classes | Class II |
| Medical specialties | Dental, General, Plastic Surgery |
| Brand names | EK NH Ultra Wide Implant; EK D3.3 NH Implant; EK SA Ultra Wide Implant; EK D3.3 SA Implant |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-07-22 |
| FDA registration number | 2219920 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (49 NJ 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: 2026-07-22
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (NJ first): MINDRAY DS USA, Inc. (contract manufacturer, Mahwah, NJ) · Isomedix Operations Inc. (contract sterilizer, Whippany, NJ) · Medin Technologies, Inc. (contract manufacturer, Totowa, NJ) · Dsv Contract Logistics LLC (repackager or relabeler, Port Re · Isomedix Operations Inc. (contract sterilizer, S Plainfield, · 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 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- Sterigenics U.S., LLC's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Sterigenics U.S., LLC in Rockaway, New Jersey?
Sterigenics U.S., LLC (Rockaway, NJ), a contract sterilizer, added 2 FDA device listings between 2026-05-07 and 2026-07-22.
How does Sterigenics U.S., LLC compare to other New Jersey DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 106 days old; check the official source for later updates before acting.
Sterigenics U.S., LLC vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics U.S., LLC | Rockaway, NJ | 2 | 69th | 2026-07-22 |
| Isomedix Operations Inc. | S Plainfield, NJ | 16 | 96th | 2026-09-28 |
| Isomedix Operations Inc. | Whippany, NJ | 26 | 98th | 2026-09-28 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New Jersey
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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.