FDA Registration Active 🇺🇸 United States

DeRoyal Industries, Inc.

Reg #: 1060680 · FEI: 1000208624 · Expires 2026
Products
134
Proprietary Names
144
Establishment Types
2
Classifications
134

Registration Details

Registration Name
DeRoyal Industries, Inc.
Registration Number
1060680
FEI Number
1000208624
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1703 Highway 33 S
City
NEW TAZEWELL
State
TN
ZIP
37825
Country
US

Regulatory Submissions

510(k) Number
K094056

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
Apparatus, Traction, Non-Powered HST
Catheter And Tip, Suction JOL
Joint, Knee, External Brace ITQ
System, Thermal Regulating DWJ
Continuous Measurement Thermometer FLL
Cannula, Surgical, General & Plastic Surgery GEA
Needle, Suturing, Disposable GAB
Electrosurgical, Cutting & Coagulation & Accessories GEI
Component, External, Limb, Ankle/Foot ISH
Kit, Surgical Instrument, Disposable KDD
Splint, Hand, And Components ILH
Orthosis, Cervical IQK
Dressing, Compression MHW
Syringe, Piston FMF
Orthosis, Cervical-Thoracic, Rigid IQF
Sling, Arm ILI
Instruments, Surgical, Cardiovascular DWS
Syringe, Balloon Inflation MAV
Dispenser, Liquid Medication KYX
Shoe, Cast IPG
Bag, Intestine KGY
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Set, Administration, Intravascular FPA
Orthosis, Limb Brace IQI
Aid, Transfer IKX
Culture Media, Non-Selective And Non-Differential JSG
Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
Injector And Syringe, Angiographic DXT
Insoles, Medical KYS
Negative Pressure Wound Therapy Powered Suction Pump OMP
Support, Patient Position CCX
Dressing, Wound, Drug FRO
Light, Surgical, Accessories FTA
Laparoscopy Kit FDE
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Stopcock, I.V. Set FMG
I.V. Start Kit LRS
Stapler, Skin QQS
Sponge, Ophthalmic HOZ
Tape And Bandage, Adhesive KGX
Joint, Elbow, External Limb Component, Mechanical IRD
Razor, Surgical LWK
Device, Occlusion, Umbilical FOD
Jelly, Lubricating, For Transurethral Surgical Instrument FHX
Laparoscope, General & Plastic Surgery GCJ
Operating Room Accessories Table Tray FWZ
Bottle, Collection, Vacuum KDQ
Garment, Protective, For Incontinence EYQ
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Drape, Surgical, Exempt PUI
Tape, Measuring, Rulers And Calipers FTY
Anti Fog Solution And Accessories, Endoscopy OCT
Mask, Surgical FXX
Insufflator, Laparoscopic HIF
Pneumoperitoneum Needle FHO
Orthosis, Corrective Shoe KNP
Suture Removal Kit MCZ
Drape, Surgical, Antimicrobial KKX
Orthosis, Lumbo-Sacral IPY
Bandage, Elastic FQM
Lavage, Jet FQH
Container, Specimen, Non-Sterile NNI
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Scalpel, One-Piece GDX
Cover, Barrier, Protective MMP
Exerciser, Non-Measuring ION
Accessories, Cleaning Brushes, For Endoscope MNL
Instrument, Surgical, Disposable KDC
Wound Dressing With Animal-Derived Material(S) KGN
Tray, Surgical, Instrument FSM
Stocking, Medical Support (For General Medical Purposes) FQL
Transducer, Ultrasonic, Diagnostic ITX
Central Venous Catheter Dressing Change Kit PEZ
Gauze/Sponge, Internal EFQ
Handle, Scalpel GDZ
Tubing, Pressure And Accessories BYX
Tube, Aspirating, Flexible, Connecting BYY
Pack, Hot Or Cold, Reusable IME
Dilator, Urethral KOE
Joint, Ankle, External Brace ITW
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Adaptor, Grooming ILW
Balloon, Epistaxis EMX
Stocking, Elastic ILG
Tube, Feeding FPD
Apparatus, Electrosurgical HAM
Cover, Limb IPM
Tray, Surgical LRP
Bag, Ice KYR
Neurosurgical Paddie HBA
Bandage, Cast ITG
Catheter, Intravascular, Diagnostic DQO
Accessory, Surgical Apparel LYU
Dressing, Wound, Occlusive NAD
Dressing, Wound, Hydrophilic NAC
Lubricant, Patient KMJ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Laparoscopic Accessories, Gynecologic NWV
Needle, Catheter GCB
Gauze/Sponge, Internal, X-Ray Detectable GDY
General Surgery Tray LRO
Device, Transfer, Patient, Manual FMR
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Syringe, Irrigating (Non Dental) KYZ
Pump, Portable, Aspiration (Manual Or Powered) BTA
Electrocautery, Gynecologic (And Accessories) HGI
Monitor, Bed Patient KMI
Protector, Skin Pressure FMP
Halter, Head, Traction HSS
Electrode, Cutaneous GXY
Pack, Hot Or Cold, Disposable IMD
Tourniquet, Nonpneumatic GAX
Applicator, Absorbent Tipped, Non-Sterile KXF
Restraint, Protective FMQ
Amniotome HGE
Adaptor, Dressing ILD
Gauze / Sponge,Nonresorbable For External Use NAB
Guide, Needle, Surgical GDF
Container, Specimen, Sterile FMH
Connector, Catheter GCD
Suture Kit OVN
Staple, Removable (Skin) GDT
Dressing Change Tray OXQ
Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
Fiber, Medical, Absorbent FRL
Probe HXB
Pack, Hot Or Cold, Water Circulating ILO
Marker, Skin FZZ
Cotton, Roll EFN
Walker, Mechanical ITJ
Blade, Scalpel GES
Tubing, Noninvasive GAZ
Instrument, Manual, Surgical, General Use MDM
Clamp, Vascular DXC

Proprietary Names

Apparatus, Traction, Non-Powered - DeRoyal Catheter and Tip, Suction - DeRoyal Joint, Knee, External Brace - DeRoyal System, Thermal Regulating - DeRoyal Thermometer, Electronic, Clinical - DeRoyal Cannula, surgical, General & Plastic Surgery - DeRoyal Needle, Suturing, Disposable - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Component, External, Limb, Ankle/Foot - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Orthosis, Cervical - DeRoyal Dressing, Compression - DeRoyal Syringe, Piston - DeRoyal Orthosis, Cervical - Thoracic, Rigid - DeRoyal Cannula, Surgical, General & Plastic Surgery - DeRoyal Sling, Arm - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Syringe, balloon inflation - DeRoyal Dispenser, Liquid Medication - DeRoyal Shoe, Cast - DeRoyal Bag, Intestine - DeRoyal Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal Set, Administration, Intravascular - DeRoyal Orthosis, Limb Brace - DeRoyal Aid, Transfer - DeRoyal Culture Media, Non-Selective and Non-Differential - DeRoyal Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal Injector and Syringe, Angiographic - DeRoyal Thermometer, electronic, clinical - DeRoyal Insoles, Medical - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Support, Patient Position - DeRoyal Dressing, Wound and Burn, Occlusive - DeRoyal Light, Surgical, Accessories - DeRoyal Laparoscopy Kit - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Stopcock, IV Set - DeRoyal Kit, I.V. Start - DeRoyal Stapler, Skin - DeRoyal Sponge, Ophthalmic - DeRoyal Tape and Bandage, Adhesive - DeRoyal Joint, Elbow, External Limb Component, Mechanical - DeRoyal Razor, Surgical - DeRoyal Device, Occlusion, Umbilical - DeRoyal Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Bottle, Collection, Vacuum - DeRoyal Garment, Protective, for Incontinence - DeRoyal Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal Drape, Surgical, Exempt - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Mask, Surgical - DeRoyal Pneumoperitoneum Needle - DeRoyal Orthosis, Corrective Shoe - DeRoyal Suture Removal Kit - DeRoyal Drape, Surgical - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal Dressing, Wound, Drug - DeRoyal Bandage, Elastic - DeRoyal Lavage, Jet - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Scalpel, One-Piece - DeRoyal Cover, Barrier, Protective - DeRoyal Exerciser, Non-Measuring - DeRoyal Accessories, Cleaning Brushes, for Endoscope - DeRoyal Instrument, Surgical, Disposable - DeRoyal Dressing, Wound, Collagen - DeRoyal Tray, Surgical, Instrument - DeRoyal Stocking, Medical Support (For General Medical Purposes) - DeRoyal Transducer, Ultrasonic, Diagnostic - BS Medical Tech Industry Central Venous Catheter Dressing Change Kit - DeRoyal Gauze/Sponge, Internal - DeRoyal Handle, Scalpel - DeRoyal Tubing, Pressure and Accessories - DeRoyal Tube, Aspirating, Flexible, Connecting - DeRoyal Pack, Hot or Cold, Reuseable - DeRoyal Dilator, Urethral Syringe, Balloon Inflation - DeRoyal Joint, Ankle, External Brace - DeRoyal Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal Adaptor, Grooming - DeRoyal Balloon, Epistaxis - DeRoyal Stocking, Elastic - DeRoyal Tube, Feeding - DeRoyal Electrosurgical, cutting & coagulation & accessories - DeRoyal Cover, Limb - DeRoyal Syringe, piston - DeRoyal Tray, Surgical - DeRoyal Bag, Ice - DeRoyal Neurosurgical Paddie - DeRoyal Bandage, Cast - DeRoyal Insufflator, Laparoscopic - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Grounding Pad Accessory, Surgical Apparel - DeRoyal Dressing, Wound, Occlusive - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Lubricant, Patient - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Laparoscopic Accessories, Gynecologic - DeRoyal Needle, Catheter - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal General surgery tray - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Syringe, Irrigating (Non Dental) - DeRoyal Pump, Portable, Aspiration (Manual or Powered) - DeRoyal Electrocautery, Gynecologic (and Accessories) - DeRoyal Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings – DeRoyal Monitor, Bed Patient - DeRoyal Protector, Skin Pressure - DeRoyal Halter, Head, Traction - DeRoyal Electrode, Cutaneous - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Restraint, Protective - DeRoyal Amniotome - DeRoyal Electrosurgical Cutting & Coagulation Accessories - DeRoyal Adaptor, Dressing - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Guide, Needle, Surgical - DeRoyal Container, Specimen, Sterile - DeRoyal Connector, Catheter - DeRoyal Suture Kit - DeRoyal Staple, Removable (Skin) - DeRoyal Dressing Change Tray - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Accessory Surgical Apparel - DeRoyal Fiber, Medical, Absorbent - DeRoyal Probe - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Marker, Skin - DeRoyal Cotton, Roll - DeRoyal Walker, Mechanical - DeRoyal Blade, Scalpel - DeRoyal Tubing, Noninvasive - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Clamp, Vascular - DeRoyal

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)