FDA Registration Active 🇺🇸 United States

DEROYAL INDUSTRIES, INC.

Reg #: 2320762 · FEI: 3003040625 · Expires 2026
Products
204
Proprietary Names
218
Establishment Types
3
Classifications
204

Registration Details

Registration Name
DEROYAL INDUSTRIES, INC.
Registration Number
2320762
FEI Number
3003040625
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1595 Highway 33 S
City
NEW TAZEWELL
State
TN
ZIP
37825
Country
US

Regulatory Submissions

510(k) Number
K003229

Owner / Operator

Firm Name
DEROYAL INDUSTRIES, INC.
Operator Number
1044833
Address
200 DEBUSK LN., --
City
Powell
State
TN
Postal Code
37849
Country
US
Correspondent
Elizabeth Reed

Products

Device Name Product Code
Container, Specimen Mailer And Storage, Sterile KDT
Securement Wound Dressing For Reduction Of Infection SEL
Tubing, Noninvasive GAZ
Absorber, Saliva, Paper KHR
Catheter, Urological KOD
Tourniquet, Nonpneumatic GAX
Electrode, Electrocardiograph DRX
Tubing, Pressure And Accessories BYX
Container, Specimen, Sterile FMH
Tissue Adhesive For The Topical Approximation Of Skin MPN
Dressing, Wound, Drug FRO
Laparoscope, General & Plastic Surgery GCJ
Clamp, Vascular DXC
Accessories, Catheter KGZ
Electrosurgical, Cutting & Coagulation & Accessories GEI
Suture, Absorbable, Natural GAL
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Nonabsorbable, Silk GAP
Insufflator, Endoscopic Vessel Harvesting OSV
Insufflator, Laparoscopic HIF
Light, Surgical, Accessories FTA
Introducer, Catheter DYB
Syringe, Irrigating (Non Dental) KYZ
Burn Kit Without Drug OJJ
Negative Pressure Wound Therapy Powered Suction Pump OMP
Transducer, Pressure, Catheter Tip DXO
Saline, Vascular Access Flush NGT
Anti Fog Solution And Accessories, Endoscopy OCT
Set, Administration, Intravascular FPA
Needle, Aspiration And Injection, Disposable GAA
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Body Fluids Barrier Kit OKH
Accessory, Surgical Apparel LYU
Slides, Microscope KEW
Wax, Bone MTJ
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Syringe, Piston FMF
Needle, Hypodermic, Single Lumen FMI
Neurosurgical Paddie HBA
Eye Tray OJK
Catheter, Intravascular, Diagnostic DQO
Drape, Surgical, Antimicrobial KKX
Applicator, Absorbent Tipped, Non-Sterile KXF
Scissors, Medical, Disposable JOK
Connector, Catheter GCD
Dressing, Wound, Occlusive NAD
Pad, Eye HMP
Tray, Surgical LRP
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
Cover, Barrier, Protective MMP
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Cardiovascular Surgical Instruments Tray OFA
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Sponge, Ophthalmic HOZ
Table, Cysto, Non-Electrical EYH
Stapler, Skin QQS
Restraint, Protective FMQ
Clean-Up Kit PWU
Staple, Removable (Skin) GDT
Instruments, Surgical, Cardiovascular DWS
Gynecological Laparoscopic Kit OHD
Clip, Implantable FZP
Pack, Hot Or Cold, Disposable IMD
Hemostat HRQ
Device, Occlusion, Umbilical FOD
Garment, Protective, For Incontinence EYQ
Gown, Surgical FYA
Laryngoscope, Endoscope GCI
Tray, Surgical, Instrument FSM
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Dressing Change Tray OXQ
Bandage, Cast ITG
Catheter, Retention Type, Balloon EZL
Catheter, Urological (Antimicrobial) And Accessories MJC
Foley Catheter Kit (Excludes Hiv Testing) PPB
Blade, Saw, General & Plastic Surgery, Surgical GFA
Lubricant, Patient KMJ
Container, I.V. KPE
Clamp HXD
Airway, Oropharyngeal, Anesthesiology CAE
Syringe, Periodontic, Endodontic, Irrigating EIC
Forceps, General & Plastic Surgery GEN
Instrument, Ligature Passing And Knot Tying HCF
General Surgery Tray LRO
Handle, Scalpel GDZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Protector, Skin Pressure FMP
Mask, Gas, Anesthetic BSJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
Gauze / Sponge,Nonresorbable For External Use NAB
Wound Dressing Kit MCY
Catheter And Tip, Suction JOL
Filter, Bacterial, Breathing-Circuit CAH
Razor, Surgical LWK
Lift, Patient, Non-Ac-Powered FSA
Lavage, Jet FQH
Clamp, Surgical, General & Plastic Surgery GDJ
Balloon, Epistaxis EMX
Tube, Aspirating, Flexible, Connecting BYY
Gauze/Sponge, Internal EFQ
Applicator, Absorbent Tipped, Sterile KXG
Speculum, Vaginal, Nonmetal HIB
Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
Kit, Surgical Instrument, Disposable KDD
Bag, Reservoir BTC
Tape, Measuring, Rulers And Calipers FTY
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Stopcock, I.V. Set FMG
Dissector, Surgical, General & Plastic Surgery GDI
System, X-Ray, Fluoroscopic, Image-Intensified JAA
Drape, Surgical, Exempt PUI
Solvent, Adhesive Tape KOX
Container, Specimen, Non-Sterile NNI
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Specula, Ophthalmic HNC
System, Thermal Regulating DWJ
Amniotome HGE
Mask, Oxygen BYG
Cotton, Roll EFN
Cannula, Manipulator/Injector, Uterine LKF
Device, Specimen Collection LIO
Catheter, Upper Urinary Tract EYC
Applier, Surgical, Clip GDO
Basin, Emesis FNY
Sound, Uterine HHM
Pad, Menstrual, Unscented HHD
Catheter, Continuous Irrigation GBQ
Tape And Bandage, Adhesive KGX
Aspiration Tray OJT
Orthopedic Manual Surgical Instrument LXH
Depressor, Tongue, Non-Surgical FMA
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Component, Traction, Non-Invasive KQZ
Tubes, Vacuum Sample, With Anticoagulant GIM
Apparatus, Exhaust, Surgical FYD
Gauze/Sponge, Internal, X-Ray Detectable GDY
Cannula, Injection FGY
Support, Patient Position CCX
Laparoscopic Accessories, Gynecologic NWV
Bandage, Liquid, Skin Protectant NEC
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Pack, Hot Or Cold, Water Circulating ILO
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Cover, Limb IPM
Sigmoidoscope And Accessories, Flexible/Rigid FAM
Marker, Skin FZZ
Laparoscope, Gynecologic (And Accessories) HET
Catheter, Urethral GBM
Pap Smear Kit OHL
Hemostat, Surgical EMD
Tourniquet Kit OJS
Tourniquet, Pneumatic KCY
Ear, Nose, And Throat Surgical Tray OGR
Laparoscopy Kit FDE
Injector And Syringe, Angiographic DXT
Dressing, Wound, Hydrophilic NAC
System, Irrigation, Urological LJH
Arthroscope HRX
Angiography/Angioplasty Kit OEQ
Scalpel, One-Piece GDX
Fiber, Medical, Absorbent FRL
Strip, Temperature, Forehead, Liquid Crystal KPD
Scissors, General, Surgical LRW
Holder, Needle, Gastroenterologic FHQ
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Electrocautery, Gynecologic (And Accessories) HGI
Bedding, Disposable, Medical KME
Speculum, Vaginal, Metal HDF
Cover, Shoe, Operating-Room FXP
Central Venous Catheter Dressing Change Kit PEZ
Catheter, Irrigation GBX
Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
Stocking, Elastic ILG
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Dispenser, Liquid Medication KYX
Continuous Measurement Thermometer FLL
Pneumoperitoneum Needle FHO
Bandage, Elastic FQM
Dressing, Compression MHW
Instrument, Cranioplasty Material Forming HBX
Infant Heel Warmer (Chemical Heat Pack) MPO
Blade, Scalpel GES
Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
Condom HIS
Operating Room Accessories Table Tray FWZ
Wrap, Sterilization FRG
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Bottle, Collection, Vacuum KDQ
Unit, Suction Operatory EBR
Skin Prep Tray OJU
Pad, Alcohol, Device Disinfectant LKB
Catheter, Coude EZC
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Gown, Isolation, Surgical FYC
Instrument, Surgical, Disposable KDC
Retractor GAD
Instrument, Manual, Surgical, General Use MDM
Jelly, Lubricating, For Transurethral Surgical Instrument FHX
System, Imaging, Pulsed Echo, Ultrasonic IYO

Proprietary Names

Container, Specimen Mailer and Storage, Sterile - DeRoyal Dressing, Wound, Drug - DeRoyal Tubing, Noninvasive - DeRoyal Absorber, Saliva, Paper - DeRoyal Catheter, Urological - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Electrode Electrocardiograph - DeRoyal Tubing, Pressure and Accessories - DeRoyal Container, Specimen, Sterile - DeRoyal Tissue Adhesive for the Topical Approximation of Skin - DeRoyal Multidex Laparoscope, General & Plastic Surgery - DeRoyal Clamp, Vascular - DeRoyal Accessories, Catheter - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Insufflator, Laparoscopic - DeRoyal Light, Surgical, Accessories - DeRoyal Introducer, Catheter - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Burn Kit without Drug - DeRoyal Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings – DeRoyal Transducer, Pressure, Catheter Tip - DeRoyal Saline, Vascular Access Flush - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Set, Administration, Intravascular - DeRoyal Needle, Aspiration and Injection, Disposable - DeRoyal Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal Body Fluid Barrier Kit - DeRoyal Accessory, Surgical Apparel - DeRoyal MICROSCOPE SLIDES - DeRoyal Wax, Bone - DeRoyal Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal Neurosurgical Paddie - DeRoyal Eye Tray - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Drape, Surgical - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Scissors, Medical, Disposable - DeRoyal Connector, Catheter - DeRoyal Dressing, Wound, Occlusive - DeRoyal Pad, Eye - DeRoyal Tray, Surgical - DeRoyal Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic - DeRoyal Cover, Barrier, Protective - DeRoyal Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal Cardiovascular Surgical Instruments Tray - DeRoyal Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal Sponge, Ophthalmic - DeRoyal Gauze/Sponge, Internal - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Table, Cysto, Non-Electrical - DeRoyal Stapler, Skin - DeRoyal Restraint, Protective - DeRoyal Clean-up Kit - DeRoyal Staple, Removeable (Skin) - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Gynecological Laparoscopic Kit - DeRoyal Clip, Implantable - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Hemostat - DeRoyal Device, Occlusion, Umbilical - DeRoyal IMD - Pack, Hot or Cold, Disposable - DeRoyal Garment, Protective, for Incontinence - DeRoyal Gown, Surgical - DeRoyal Laryngoscope, Endoscope - DeRoyal Tray, Surgical, Instrument - DeRoyal Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal Dressing Change Tray - DeRoyal Bandage, Cast - DeRoyal Catheter, Urological (antimicrobial) and Accessories - DeRoyal Foley Catheter Kit (excludes HIV testing) - DeRoyal Syringe, Piston - DeRoyal Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal Lubricant, Patient - DeRoyal Container, I. V. - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal CLAMP - DeRoyal Airway, Oropharyngeal, Anesthesiology - DeRoyal Syringe, Periodontic, Endodontic, Irrigating - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Instrument, Ligature Passing & Knot Typing - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Handle, Scalpel - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Protector, Skin Pressure - DeRoyal Gas Mask-Anesthesia - DeRoyal Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Kit, Wound Dressing - DeRoyal Catheter and Tip, Suction - DeRoyal Filter, Bacterial, Breathing - Circuit - DeRoyal Razor, Surgical - DeRoyal Staple, Removable (Skin) - DeRoyal Lift, Patient, Non-AC-Powered - DeRoyal Lavage, Jet - DeRoyal Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Balloon, Epistaxis - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Speculum, Vaginal, Nonmetal - DeRoyal Streamway Needle, Conduction, Anesthetic (w/wo Introducer)- DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Bag, Reservoir - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal Stopcock, IV Set - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal Drape, Surgical, Exempt - DeRoyal Solvent, Adhesive Tape - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Specula, Ophthalmic - DeRoyal System, Thermal Regulating - DeRoyal Amniotome - DeRoyal Mask, Oxygen - DeRoyal Cotton, Roll - DeRoyal Cannula, Manipulator/Injector, Uterine - DeRoyal Device, Specimen Collection - DeRoyal Catheter, Upper Urinary Tract - DeRoyal Clip, Implantable - Add Basin, Emesis - DeRoyal Sound, Uterine - DeRoyal Pad, Menstrual, Unscented - DeRoyal Catheter, Continuous Irrigation - DeRoyal Tape and Bandage, Adhesive - DeRoyal Aspiration Tray (Kit) - DeRoyal Ortho Manual Surgical Instrument - DeRoyal Depressor, Tongue, Non-Surgical - DeRoyal Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal Catheter, Retention Type, Balloon - DeRoyal Component, Traction, Non-Invasive - DeRoyal General surgery tray - DeRoyal Tubes, Vacuum Sample, with Anticoagulant - DeRoyal Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Silver Alginate Cath Patch Dressing - DeRoyal Apparatus, Exhaust, Surgical - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Cannula Vial Access - DeRoyal Support, Patient Position - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Bandage, Liquid, Skin Protectant - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Cover, Limb - DeRoyal Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal Marker, Skin - DeRoyal Laparoscope, Gynecologic (and accessories) - DeRoyal Dressing, Wound, Drug, Lavage, Jet - DeRoyal Catheter, Urethral - DeRoyal Applier, Surgical, Clip - DeRoyal Pap Smear Kit - DeRoyal Hemostat, Surgical - DeRoyal Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal Tourniquet Kit - DeRoyal Tourniquet, Pneumatic - DeRoyal Ear, Nose, and Throat Surgical Tray - DeRoyal Laparoscopy Kit - DeRoyal Yankauer - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal System, irrigation, Urological - DeRoyal Angiography/Angioplasty Kit - DeRoyal Injector and Syringe, Angiographic - DeRoyal Scalpel, One-Piece - DeRoyal Fiber, Medical, Absorbent - DeRoyal Strip, Temperature, Forehead, Liquid Crystal - DeRoyal Sensostrip Temperature Sensor Scissors, General, Surgical - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Stopcock 1 Way High Pressure Bedding Disposable, Medical - DeRoyal Speculum, Vaginal, Metal - DeRoyal Cover, Shoe, Operating-room - DeRoyal Central Venous Catheter Dressing Change Kit - DeRoyal Catheter, Irrigation - DeRoyal Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal Stocking, Elastic - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Dispenser, Liquid Medication - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal Thermometer, electronic, clinical - DeRoyal Pneumoperitoneum Needle - DeRoyal Bandage, Elastic - DeRoyal Dressing, Compression - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Nepcell Infant Heel Warmer (Chemical Heat Pack) - DeRoyal Blade, Scalpel - DeRoyal Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal Condom - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Wrap, Sterilization - DeRoyal Circuit, Breathing (w Connector, Adaptor, Y Piece) - DeRoyal Bottle, Collection, Vacuum - DeRoyal Unit, Suction Operatory - DeRoyal Skin Prep Tray (Kit)- DeRoyal Grounding Pad Pad, Alcohol, Device Disinfectant - DeRoyal Laparoscope General and Plastic Surgery - DeRoyal Catheter, Coude - DeRoyal Syringe Piston - DeRoyal Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal Instrument, Surgical, Disposable - DeRoyal Retractor - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Reprocess Single-Use Device