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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1992-10-28 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2012-09-20 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2006-06-20 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2015-11-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-03-28 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2012-10-24 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1997-11-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-01-27 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 1991-04-03 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2006-06-20 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2006-06-20 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2004-12-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-05-19 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2017-04-27 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2006-07-27 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-08-28 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2012-10-24 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2005-08-25 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2006-06-20 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2012-11-02 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2012-11-16 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-05-22 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2006-06-20 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2012-08-27 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2020-07-14 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2016-05-17 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2017-04-19 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2012-11-02 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2025-12-02 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2005-08-08 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2013-01-30 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2015-09-22 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2016-03-07 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-09-22 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2017-11-01 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2015-12-10 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2022-04-06 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2015-09-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-04-04 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2016-08-31 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2012-09-20 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 1997-02-12 |
| Jelly, Lubricating, For Transurethral Surgical Instrument | FHX | Class 2 | Gastroenterology, Urology | No | 2011-06-28 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-05-23 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2012-09-28 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2004-10-19 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-01-13 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2015-11-23 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-01 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2009-08-24 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-10-26 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2016-06-22 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2016-06-22 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2006-06-20 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2015-12-10 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2024-01-02 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2006-06-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2006-08-09 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2011-12-30 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2006-08-22 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2012-09-25 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2011-09-19 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 1994-11-10 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-02-08 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2001-02-21 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2014-09-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-05-16 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2013-03-04 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-12-16 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2015-12-10 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2010-01-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2012-09-17 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2012-09-20 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2004-11-03 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2001-08-03 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2015-08-25 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-08-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2012-09-17 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2015-09-22 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2016-01-13 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2015-09-25 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2012-11-16 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2022-07-18 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2001-08-03 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2001-02-06 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 1992-10-28 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2016-01-27 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2005-08-08 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2021-02-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-12-09 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-06-23 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2015-09-17 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2024-02-19 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2012-11-02 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2012-02-28 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2016-03-07 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2018-11-01 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2009-08-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 1997-10-23 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2012-11-02 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2013-01-24 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2014-02-10 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2006-07-27 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 2006-08-09 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2012-11-02 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2006-08-09 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2001-08-03 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2015-09-15 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2001-08-03 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2015-09-22 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1994-01-04 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-01-27 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2004-03-03 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2012-09-25 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2016-02-08 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 1991-07-15 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-12-10 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2009-12-30 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2006-08-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2026-01-13 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 1997-02-28 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2004-10-15 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2012-03-22 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1998-08-19 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2005-06-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2011-05-05 |
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)