FDA Registration Active 🇺🇸 United States

DUKAL LLC

Reg #: 2435946 · FEI: 1000137528 · Expires 2026
Products
95
Proprietary Names
109
Establishment Types
2
Classifications
95

Registration Details

Registration Name
DUKAL LLC
Registration Number
2435946
FEI Number
1000137528
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
2 Fleetwood Ct.
City
Ronkonkoma
State
NY
ZIP
11779
Country
US

Regulatory Submissions

510(k) Number
K070407

Owner / Operator

Firm Name
DUKAL LLC
Operator Number
9005925
Address
2 Fleetwood Ct, --
City
Ronkonkoma
State
NY
Postal Code
11779
Country
US
Correspondent
Kara - Mckigney

Products

Device Name Product Code
Holder, Film, X-Ray EGZ
Mask, Surgical FXX
Bedding, Disposable, Medical KME
Stool, Operating-Room FZM
Dressing, Wound, Occlusive NAD
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Adaptor, Hygiene ILS
Depressor, Tongue, Non-Surgical FMA
Container, Specimen, Non-Sterile NNI
Pill Crusher/Cutter OHY
Cement, Dental EMA
Container, Embedding KER
Non-Surgical Gown OEA
Heat Source For Bleaching Teeth EEG
Toothbrush, Manual EFW
First Aid Kit With Drug LRR
Dressing, Wound, Drug FRO
Dressing, Wound, Hydrophilic NAC
Applicator, Absorbent Tipped, Non-Sterile KXF
Pad, Eye HMP
Bandage, Cast ITG
Cup, Prophylaxis EHK
Tourniquet Kit OJS
Wheelchair, Mechanical IOR
Bedpan FOB
Speculum, Vaginal, Nonmetal HIB
Tray, Impression, Preformed EHY
Scissors, Medical, Disposable JOK
Media, Coupling, Ultrasound MUI
Cover, Shoe, Operating-Room FXP
Razor, Surgical LWK
Mouthpiece, Saliva Ejector DYN
Cleanser, Denture, Over The Counter EFT
Gauze/Sponge, Internal EFQ
Material, Impression ELW
Stand, Infusion FOX
Polymer Patient Examination Glove LZA
Applicator, Absorbent Tipped, Sterile KXG
Tourniquet, Nonpneumatic GAX
Pinwheel GWY
Stethoscope, Manual LDE
Disinfectant, Medical Devices LRJ
Syringe, Restorative And Impression Material EID
Tracheostomy And Nasal Suctioning Kit LRQ
Syringe, Irrigating (Dental) EIB
Tape, Measuring, Rulers And Calipers FTY
Accessory, Surgical Apparel LYU
Instrument, Manual, Surgical, General Use MDM
Protector, Skin Pressure FMP
Tape And Bandage, Adhesive KGX
Wrap, Sterilization FRG
Indicator, Physical/Chemical Sterilization Process JOJ
Pad, Alcohol, Device Disinfectant LKB
Basin, Emesis FNY
Dispenser, Solid Medication NXB
Forceps HTD
Tray, Surgical, Instrument FSM
Drape, Surgical, Exempt PUI
Unit, Syringe, Air And/Or Water ECB
Floss, Dental JES
Sponge, Ophthalmic HOZ
Tray, Fluoride, Disposable KMT
Suture Removal Kit MCZ
First Aid Kit Without Drug OHO
Lubricant, Patient KMJ
Blood Pressure Cuff DXQ
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Absorber, Saliva, Paper KHR
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Dental Barriers And Sleeves PEM
Gauze / Sponge,Nonresorbable For External Use NAB
Cap, Surgical FYF
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Cotton, Roll EFN
Strip, Adhesive, Closure, Skin FPX
Finger Cot LZB
Vinyl Patient Examination Glove LYZ
Pack, Hot Or Cold, Disposable IMD
Gauze/Sponge, Internal, X-Ray Detectable GDY
Container, Liquid Medication, Graduated KYW
Handle, Instrument, Dental EJB
Gown, Examination FME
Bandage, Elastic FQM
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt KOO
Fiber, Medical, Absorbent FRL
Unit, Operative Dental, Accessories NRD
Chair, Blood Donor FML
Percussor GWZ
Fork, Tuning GWX
Dressing, Compression MHW
Chair, Dental, Without Operative Unit NRU
Sling, Arm ILI
Splint, Hand, And Components ILH
Chart, Visual Acuity HOX
Evacuator, Oral Cavity EHZ

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 Private Label Vinyl Patient Exam gloves Dukal Instant Cold Packs DUKAL Instant Hot Packs Color Change Alginate Fast Set (Private Label Brand) Dukal Sterile Petrolatum Dressing Dukal Sterile Oil Emulsion Dressing Dukal LAP SPONGE Prewash Xray Dukal Medicine Cup Unipack Micro Applicators Dukal Patient Exam Gown DUKAL ELASTIC BANDAGE LATEX DawnMist Denture Adhesive Dukal Cotton Balls Dukal Air Water Syringe Sleeves Tech-Med Blood Draw Chair Tech-Med Babinski Percussion Hammer Tech-Med Aluminum Tuning Fork Dukal Gauze Burn Dressing Dukal Headrest Covers Dukal TRIANGULAR BANDAGE Tech-Med Finger Guard Tech-Med Illuminated Snellen Eye Chart Dukal Evacuation Products & Accessories, including Private Label.

Establishment Types

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