Sterigenics U.S. LLC (contract sterilizer, Mulberry, FL): 1 new FDA device listing, incl. fastener, fixation, nondegradable, soft tissue
Sterigenics U.S. LLC (Mulberry, Florida): 1 new FDA device listing, incl. fastener, fixation, nondegradable, soft tissue. Its amount of 1 is above the median of 1 (50th percentile). Dated 154 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 83 related FL 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 | Mulberry, FL, US |
| New listings | 1 |
| Devices | Fastener, Fixation, Nondegradable, Soft Tissue |
| Product codes | MBI |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Infinity Large Tibial Button; Infinity Standard Tibial Button; Infinity Adjustable Loop Button Cradle; Infinity Femoral Adjustable Loop Button; Infinity Adjustable Free Loop |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1054811 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (84 FL 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: 2026-06-04
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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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 84 Florida peers
- Florida DeviceEstablishmentPulse records like this one: 84
- Sterigenics U.S. LLC's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $16,800 (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 Mulberry, Florida?
Sterigenics U.S. LLC (Mulberry, FL), a contract sterilizer, added 1 FDA device listing on 2026-06-04.
How does Sterigenics U.S. LLC compare to other Florida DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 154 days old; check the official source for later updates before acting.
Sterigenics U.S. LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics U.S. LLC | Mulberry, FL | 1 | 50th | 2026-06-04 |
| Isomedix Operations Inc. | Chester, NY | 3 | 77th | 2026-09-28 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Florida
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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.