Dukal LLC (specification developer, Ronkonkoma, NY): 3 new FDA device listings, incl. wound dressing with animal-derived material(s)
Dukal LLC (Ronkonkoma, New York): 3 new FDA device listings, incl. wound dressing with animal-derived material(s). Its amount of 3 is above the median of 2 (77th percentile). Dated 135 days ago, it serves as a historical benchmark. Score 70/100. 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: 57 related NY DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Dukal LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Ronkonkoma, NY, US |
| New listings | 3 |
| Devices | Wound Dressing With Animal-Derived Material(S); Vinyl Patient Examination Glove; Polymer Patient Examination Glove |
| Product codes | KGN, LYZ, LZA |
| Device classes | Class I, Unclassified |
| Medical specialties | General Hospital |
| Brand names | RENCURA Sterile Collagen Wound Dressing; Private Label Vinyl Patient Exam gloves; Private Label Polymer (Nitrile) patient examination glove |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 2435946 |
| Registration expires | 2027-12-31 |
| amount percentile | 77th of 2,709 (median 2, 1.5x median) |
| Peer records CSV (58 NY 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: 2026-06-23
- Data refreshed: 2026-11-04
- 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, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Dukal LLC and 58 New York peers
- New York DeviceEstablishmentPulse records like this one: 58
- Dukal LLC's amount: 77th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $11,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Dukal LLC in Ronkonkoma, New York?
Dukal LLC (Ronkonkoma, NY), a specification developer (outsources manufacturing), added 3 FDA device listings between 2026-05-11 and 2026-06-23.
How does Dukal LLC compare to other New York DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 135 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Dukal LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Dukal LLC | Ronkonkoma, NY | 3 | 77th | 2026-06-23 |
| Centinel Spine, LLC | West Chester, PA | 3 | 77th | 2026-10-22 |
| TORNIER Inc. | Columbia City, IN | 3 | 77th | 2026-10-21 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New York
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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.