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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2025-02-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-02-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2006-10-03 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 2016-05-13 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2008-01-02 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2016-05-13 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2002-03-08 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-08-30 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2016-05-13 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2021-07-22 |
| Container, Embedding | KER | Class 1 | Pathology | No | 2016-05-13 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2007-10-22 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2023-07-26 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2012-11-14 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2007-10-30 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-03-16 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2006-10-02 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2002-03-08 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2006-08-10 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2014-08-22 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2021-07-22 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2023-01-18 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2016-07-19 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2024-11-04 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-07-22 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2006-03-30 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2026-01-06 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2004-02-20 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2012-11-14 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2021-07-22 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2012-11-14 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2016-03-16 |
| Material, Impression | ELW | Class 2 | Dental | No | 2021-07-22 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2016-05-13 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2026-05-11 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2007-11-14 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2006-03-30 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2016-05-16 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2016-05-13 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2021-07-22 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2021-07-22 |
| Tracheostomy And Nasal Suctioning Kit | LRQ | Class 1 | Unknown | No | 2018-04-18 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2021-07-22 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-06-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2004-02-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-05-13 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-12-19 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2002-03-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2019-08-09 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2019-08-09 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2014-08-13 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2016-05-13 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2016-05-13 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-01-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-05-13 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-10-23 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2024-01-21 |
| Floss, Dental | JES | Class 1 | Dental | No | 2012-11-14 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2025-04-24 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2021-07-22 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2008-04-14 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2018-05-09 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2012-05-11 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2016-05-13 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-07-22 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2019-06-26 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2019-01-30 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2021-08-17 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2004-02-20 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2006-10-03 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2016-05-13 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2004-02-20 |
| Strip, Adhesive, Closure, Skin | FPX | Class 1 | General Hospital | No | 2006-11-09 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2016-05-16 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2026-05-11 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2007-08-02 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2005-05-16 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2013-12-09 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2021-07-22 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2015-11-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1995-05-11 |
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | Class 1 | Dental | No | 2020-07-01 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2006-10-02 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2019-08-12 |
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2016-05-13 |
| Percussor | GWZ | Class 1 | Neurology | No | 2016-05-13 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2016-05-16 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2015-01-09 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2019-08-12 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2005-05-16 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2016-05-13 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2016-05-13 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2020-12-08 |
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