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Dukal LLC

US

Last updated September 17, 2026

Information

Country
US
Address
2 Fleetwood Ct., Ronkonkoma, NY, 11779
Website
dukal.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(631)656-3800
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1000137528
DUNS Number
791014871

Catalogue (792)

Page 16 of 16
DeviceModel / ReferenceRegistriesClassStatus
Ouch Essentials 17061001
FDA UDI
Class IActive
American White Cross 1612033
FDA UDI
Class IActive
American White Cross PVJ2D
FDA UDI
Class IActive
Rencura RCCS48
FDA UDI
UActive
American White Cross 10608
FDA UDI
Class IActive
American White Cross 7675033
FDA UDI
Class IActive
Rencura RCCA22
FDA UDI
Class IActive
American White Cross 15960
FDA UDI
Class IActive
American White Cross 7575033 and 75911
FDA UDI
Class IActive
American White Cross 77631
FDA UDI
Class IActive
American White Cross 10658
FDA UDI
Class IActive
Rencura RCCA12
FDA UDI
Class IActive
American White Cross 10663
FDA UDI
Class IActive
American White Cross 1415033
FDA UDI
Class IActive
American White Cross 12303
FDA UDI
Class IActive
Unipack UBC-8045
FDA UDI
Class IIActive
American White Cross 19927
FDA UDI
Class IActive
American White Cross 1622033
FDA UDI
Class IActive
American White Cross 77630
FDA UDI
Class IActive
American White Cross 89115
FDA UDI
Class IActive
American White Cross 1510033
FDA UDI
Class IActive
American White Cross 1087744
FDA UDI
Class IUnknown
American White Cross 1490033
FDA UDI
Class IActive
Dukal Skin Closure Strip K931005
FDA 510(k)
Class IActive
Dukal Surgical Face Mask Tie, Ear Loop, With Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow, White, And Blue K070407
FDA 510(k)
Class IIActive
Dukal Abd Combine Pad K970457
FDA 510(k)
UActive
Dukal SMS Sterilization Wrap K233262
FDA 510(k)
Class IIActive
Dukal Surgical Face Mask Tie-On, Model 1530; Ear Loop, Model 1540; With Shield, Model 1560 K061864
FDA 510(k)
Class IIActive
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K203237
FDA 510(k)
Class IIActive
Dukal Disposable Vaginal Speculum, Small, Medium, And Large K020726
FDA 510(k)
Class IIActive
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201732
FDA 510(k)
Class IIActive
Ethyl Chloride Dispenser K984564
FDA 510(k)
UActive
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons K201421
FDA 510(k)
Class IIActive
Dukal Lubricating Jelly K113689
FDA 510(k)
Class IActive
Dukal Corporation Level 1 Pediatric Face Mask K210321
FDA 510(k)
Class IIActive
Dukal Corporation AAMI Level 4 Open-Back Protective Gown K212464
FDA 510(k)
Class IIActive
Dukal Surgical Drape; Fenestrated Dukal Surgical Drape K083320
FDA 510(k)
Class IIActive
Gauze Sponge K936095
FDA 510(k)
UActive
Dukal N95particulate Respirator/Surgical Face Mask K070692
FDA 510(k)
Class IIActive
Dukal Non Adherent Dressing K970455
FDA 510(k)
UActive
Dukal Non-Woven Gauze K940440
FDA 510(k)
UActive
Dukal Transparent Wound Dressing K955476
FDA 510(k)
UActive

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jun 1, 2017Z-0233-2018—terminated

Intact carton revealed presence of shredded burn sheets