Steris Isomedix Puerto Rico, Inc. (contract sterilizer, Alts De Cerro Gordo 3&4, PR): 3 new FDA device listings, incl. thoracolumbosacral pedicle screw system

Steris Isomedix Puerto Rico, Inc. (Alts De Cerro Gordo 3&4, Puerto Rico): 3 new FDA device listings, incl. thoracolumbosacral pedicle screw system. Its amount of 3 is above the median of 2 (77th percentile). Dated 183 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 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median

Free preview: all 14 published fields of this record are shown below. Locked: 6 related PR DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSteris Isomedix Puerto Rico, Inc.
Owner / operatorSTERIS Corporation
RoleContract sterilizer
Establishment typesSterilize Medical Device for Another Party (Contract Sterilizer)
LocationAlts De Cerro Gordo 3&4, PR, US
New listings3
DevicesThoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Intervertebral Body; Appliance, Fixation, Spinal Interlaminal
Product codesNKB, KWQ, KWP
Device classesClass II
Medical specialtiesOrthopedic
First new listing2026-05-06
Latest new listing2026-05-06
FDA registration number2648623
Registration expires2027-12-31
amount percentile77th of 2,709 (median 2, 1.5x median)
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  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-05-06
  • Data refreshed: 2026-11-04
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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: Steris Isomedix Puerto Rico, Inc. and 7 Puerto Rico peers

  • Puerto Rico DeviceEstablishmentPulse records like this one: 7
  • Steris Isomedix Puerto Rico, Inc.'s amount: 77th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Puerto Rico peer: $1,400 (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 Steris Isomedix Puerto Rico, Inc. in Alts De Cerro Gordo 3&4, Puerto Rico?

Steris Isomedix Puerto Rico, Inc. (Alts De Cerro Gordo 3&4, PR), a contract sterilizer, added 3 FDA device listings on 2026-05-06.

How does Steris Isomedix Puerto Rico, Inc. compare to other Puerto Rico DeviceEstablishmentPulse records?

Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 183 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.

Steris Isomedix Puerto Rico, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Steris Isomedix Puerto Rico, Inc.Alts De Cerro Gordo 3&4, PR377th2026-05-06
Isomedix Operations Inc.San Diego, CA483rd2026-10-23
Isomedix Operations, IncOntario, CA790th2026-10-15
Isomedix Operations, Inc.Libertyville, IL790th2026-10-15

Related records

DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment

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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.

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