Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2435946

FEI Number

1000137528

Entity Name

DUKAL LLC

City/State/Country

Ronkonkoma, NY, US

Establishment Address

2 Fleetwood Ct., Ronkonkoma, NY 11779, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

DUKAL LLC (Owner Number: 9005925)

Owner / Operator Contact Address

2 Fleetwood Ct, --, Ronkonkoma, NY 11779, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Private label-Self-Adhesive Bite-Wing Tabs Dukal Surgical Mask Dukal Fluff Under Pad Tech-Med Bariatric Foot Stool, Chrome Dukal & Private label Transparent (including Sterile),Sterile Hydrocolloid, Silicone Foam/Foam Dressings & Hydrocolloid Blister Bandages Dukal Burn Dressing Tech-Med Hair Rinsette DUKAL TONGUE DEPRESSOR Dukal Plastic Cups(including private label brands) Tech-Med Pill Crusher Temporary Cement (Private Label Brand) Tech-Med Stainless Dressing Jar DUKAL ISOLATION GOWN Cavex Bite&White In-Office Starter Pack 25% HPS DawnMist Toothbrush First Aid Kit(Multiple private Label Brands) Dukal Sterile Xeroform Dressings Dukal ABD PAD DUKAL Cotton Tip Applicator DUKAL EYE PAD Dukal Cotton Undercast Pad Unipack Prophy Angles Tourniiquet Kit(Private Label Brand) Tech-Med Wheelchair Tech-Med Stainless Steel Bed Pan Dukal Disposable Vaginal Speculums Unipack Impression Trays Perforated Dukal Handled Scissor Dukal Brand -Ultrasound Transmission gel- Non-Sterile DUKAL SHOE COVERS NON SKID DawnMist Prep Razor Saliva Ejectors(Multiple Private Label Brands) DawnMist Denture Cleanser Tablets Dukal Surgical Mask, Level 3 Dukal Sterile Packing Strips, Plain Cream Alginate (Private Label Brand) Tech-Med IV Stand Private Label Polymer (Nitrile) patient examination glove Dukal Cotton Tipped Applicator - Sterile DUKAL Tourniquet, Non-Latex Tech-Med Wartenberg Pinwheel Tech-Med Dual Head Stethoscope ImpreSafe(Private Label Brand) Unipack Pre-Bent Dispensing Tips Dukal Sterile Trach Care Kit Unipack Air/Water Syringe Tips Tech-Med Paper Tape Measure DUKAL Protective Coverall with Hood Tech-Med Mayo Stand Dukal Ankle Keeper AFO Dukal Plastic Adhesive Strip Dukal Sterilization Pouch Dukal Alcohol Prep Pad Tech-Med Stainless Steel Emesis Basin Tech-Med Weekly Pill Box Dukal Splinter Forcep Dukal Sterile Packing Strips, Iodoform Unipack Sterilization Tape Steam Private label Autoclave Indicator Tape Tech-Med Stainless Steel Instrument Tray Dukal Sterile Surgical Drapes, Fenestrated Unipack Air/Water Syringe Tips, including private label. Flosser/Toothpick(Private Label Brand) Dukal Sterile Eye Spears Rencura Calcium Alginate Dressing with Silver Impressional Alginate (Private Label Brand) Unipack Fluoride Trays Dukal Surgical Mask, Level 2 Dukal Suture Removal Kit First Aid Kit (Multiple Private Label Brands) Dukal Sterile Lubricating Jelly Tech-Med Deluxe Black Sphygmomanometer Unipack Sterilization Pouches Tech-Med Sphygmomanometers/Manometers Orthotrace Alginate X-Fast Set(Private Label Brand) Dukal Sterile Antimicrobial Bandages Dukal Patient Bibs Dukal Brand-Ultrasound transmission gel-Sterile Bone Dust Collector(Private Label Brand) Unipack Barrier Film DUKAL GAUZE PAD Dukal Bouffant Caps Tech-Med Fox Aluminum Eye Shield with Cover Dukal Cotton Roll DUKAL WOUND CLOSURE STRIPS Tech-Med Latex Finger Cot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2025-02-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-27
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2006-10-03
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-05-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2008-01-02
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-04-30
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2016-05-13
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2002-03-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-08-30
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2016-05-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-07-22
KER	Container, Embedding	Pathology	Class 1	864.3010	2016-05-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2007-10-22
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2023-07-26
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2012-11-14
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2007-10-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-03-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2006-10-02
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2002-03-08
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2006-08-10
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-08-22
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2021-07-22
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2018-11-29
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-01-18
FOB	Bedpan	General Hospital	Class 1	880.6730	2016-07-19
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-11-04
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2021-07-22
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2006-03-30
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2026-01-06
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2004-02-20
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-14
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2021-07-22
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2012-11-14
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-03-29
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2016-03-16
ELW	Material, Impression	Dental	Class 2	872.3660	2021-07-22
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2016-05-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-05-11
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2007-11-14
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2006-03-30
GWY	Pinwheel	Neurology	Class 1	882.1750	2016-05-16
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2016-05-13
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-07-22
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2021-07-22
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2018-04-18
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2021-07-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-06-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2004-02-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-05-13
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-12-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2002-03-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-08-09
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2019-08-09
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2014-08-13
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2016-05-13
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2016-05-13
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-01-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-03-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2026-03-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-05-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-10-23
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2024-01-21
JES	Floss, Dental	Dental	Class 1	872.6390	2012-11-14
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2025-04-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2021-07-22
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2021-07-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-09-27
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2008-04-14
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-05-09
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2012-05-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-05-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-07-22
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-12-01
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2020-12-01
ELW	Material, Impression	Dental	Class 2	872.3660	2021-07-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-11-07
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-06-26
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2026-01-06
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2019-01-30
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2021-08-17
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2004-02-20
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2006-10-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2016-05-13
EFN	Cotton, Roll	Dental	Class 1	872.6050	2004-02-20
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2006-11-09
LZB	Finger Cot	General Hospital	Class 1	880.6250	2016-05-16

Official Correspondent

Kara Mckigney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DUKAL LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2435946. Last updated year: 2026. Please use registration number 2435946 when referencing this establishment in official correspondence.