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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2001-11-28 |
| Securement Wound Dressing For Reduction Of Infection | SEL | Class U | Unknown | No | 2024-12-13 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2024-12-13 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2023-11-14 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2015-11-10 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2024-12-13 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2004-11-03 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2004-03-03 |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2022-08-15 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2010-08-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-12-13 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2015-11-09 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2004-06-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-01-27 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2016-01-15 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2024-12-13 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-12-13 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2015-09-22 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-01-20 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 1997-10-23 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2015-12-10 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2014-05-15 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2022-01-26 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2024-01-16 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2009-08-24 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-05-23 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-05-12 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2024-05-24 |
| Body Fluids Barrier Kit | OKH | Class 2 | General, Plastic Surgery | No | 2016-02-08 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2005-08-25 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2004-07-12 |
| Wax, Bone | MTJ | Class U | Unknown | No | 2016-02-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-05-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-05-22 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2016-01-27 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2017-07-31 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-05-24 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2024-01-02 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2001-08-03 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 1998-08-07 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2012-09-25 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2004-12-09 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2016-01-27 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2001-02-06 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2010-08-23 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2011-09-19 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2016-01-13 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2021-05-24 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2016-03-07 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2015-09-17 |
| Table, Cysto, Non-Electrical | EYH | Class 1 | Gastroenterology, Urology | No | 2012-09-25 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2022-04-06 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2015-09-15 |
| Clean-Up Kit | PWU | Class 1 | General Hospital | No | 2021-08-11 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2024-05-24 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-08-28 |
| Gynecological Laparoscopic Kit | OHD | Class 2 | Obstetrics/Gynecology | No | 2016-03-07 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2014-08-01 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2006-08-09 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 1997-02-12 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-01-13 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2024-12-13 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2025-01-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-05-16 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2024-05-24 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-12-10 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2005-08-08 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-08-06 |
| Catheter, Urological (Antimicrobial) And Accessories | MJC | Class 2 | Gastroenterology, Urology | No | 2024-08-06 |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | Class 2 | Gastroenterology, Urology | No | 2018-01-02 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2005-06-23 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2015-09-17 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2024-01-15 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2012-09-28 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2017-07-17 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2004-12-09 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2016-06-03 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2012-09-17 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2005-08-25 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2006-07-27 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2004-06-25 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2024-01-22 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1994-01-04 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2015-12-10 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-12-13 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2017-11-14 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2012-09-20 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2024-12-13 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2011-12-30 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2024-07-23 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2016-01-13 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2004-11-03 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2012-09-21 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2004-06-23 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2015-09-17 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2025-05-14 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2012-09-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2013-12-24 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2024-05-23 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2001-08-03 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2012-09-04 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-01 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2016-02-08 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2006-08-22 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2013-02-15 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2009-08-21 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2016-05-17 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2024-12-13 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2001-08-03 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2016-01-13 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2004-10-15 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2024-12-13 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2025-08-06 |
| Catheter, Upper Urinary Tract | EYC | Class 2 | Gastroenterology, Urology | No | 2020-11-19 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2024-05-23 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2001-05-16 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2024-05-24 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2012-09-25 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2015-11-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-04-04 |
| Aspiration Tray | OJT | Class 1 | General, Plastic Surgery | No | 2016-05-17 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2010-08-10 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2001-08-03 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2012-09-28 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2006-08-22 |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | Class 2 | Clinical Chemistry | No | 2012-09-17 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2016-01-14 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2016-03-07 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2005-08-08 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2012-11-02 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2016-02-08 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-09-22 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 1997-02-28 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2012-09-17 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2001-08-03 |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | Class 2 | Gastroenterology, Urology | No | 2012-09-26 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2024-12-13 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2021-11-04 |
| Pap Smear Kit | OHL | Class 2 | Obstetrics/Gynecology | No | 2016-03-07 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2024-05-02 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2016-02-08 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2024-12-13 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2016-09-22 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2016-03-07 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-01-14 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2004-06-23 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2024-12-13 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-12-13 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2016-03-07 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2006-08-22 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 1998-03-16 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2004-12-09 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2012-09-17 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2015-11-23 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2013-01-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2005-04-14 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2024-05-24 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2016-02-08 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2015-12-10 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2005-04-20 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2024-12-13 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2015-09-25 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2012-09-25 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2005-08-25 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2010-09-10 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2016-06-22 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2006-08-09 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2004-12-09 |
| Instrument, Cranioplasty Material Forming | HBX | Class 1 | Neurology | No | 2024-11-12 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2007-12-28 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1998-08-19 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2012-09-28 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2012-09-17 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2012-09-28 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2022-06-14 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2005-08-25 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2004-10-19 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2016-01-13 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2016-03-07 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2016-02-08 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2022-09-20 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2015-11-20 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2024-05-23 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2001-02-21 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-08-22 |
| Jelly, Lubricating, For Transurethral Surgical Instrument | FHX | Class 2 | Gastroenterology, Urology | No | 2011-06-28 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2016-02-08 |
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