Profile: DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable straps to vary the amount of stretch. Its dorsiflexion design applies stretch for effective pain relief during the night. Our surgical nad medical products include surgical accessories, orthopedic drapes & dressings, sponges & towels, specialty put-ups, temperature monitoring, equipment covers & drapes, blades & scalpels, blood pressure cuffs, endoscopic & laparoscopic products, electrosurgical products, wound & incision closure & dressings and surgical positioners. Our services include waste fluid management and facial protection.
The company was founded in 1976, has revenues of USD 1-5 Million, has ~30 employees and is ISO certified.
FDA Registration Number: 1048770
|• Abdominal Binders (FDA Code: FSD / 880.5160)|
|• Absorbable Gauze, Dressing|
|• Acromioclavicular Splint|
|• Adenoid Sponges|
|• Adhesive Bandages (FDA Code: KGX / 880.5240)|
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
|• Adhesive Elastic Bandage Tape|
|• Adhesive Strips & Patches|
|• Adhesive Tape|
|• Adult Blood Pressure Inflation Cuffs|
|• Adult Tongue Depressor (FDA Code: FMA / 880.6230)|
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
|• Adult Wheelchairs|
|• Aluminum Finger Splints|
|• Amniotome (FDA Code: HGE / 884.4530)|
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
|• Anesthesia Ring|
|• Anesthetic Gas Mask (FDA Code: BSJ / 868.5550)|
An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.
|• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650)|
An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
|• Ankle and Foot Braces|
|• Ankle Braces|
|• Ankle Braces & Supports|
|• Ankle Foot Orthosis|
|• Arm Slings (FDA Code: ILI / 890.3640)|
An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
|• Articulating Walker|
|• Automatic Autoclaves|
|• Automatic Surgical Stapler (FDA Code: GAG / 878.4800)|
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
|• Back Braces & Supports|
|• Bariatric Abdominal Binder|
|• Bedpan (FDA Code: FOB / 880.6730)|
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
|• Blood & Components Collection Container (FDA Code: KSR / 864.9100)|
An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
|• Blood Collection Sets with Needle Holder|
|• Blood Needle Holder Systems|
|• Blood pressure Cuffs (FDA Code: DXQ / 870.1120)|
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
|• Blotter Accessories, Blotter Sponges|
|• Bone Clamp (FDA Code: HXD / 878.4800)|
|• Bone Fixation Plate (FDA Code: HRS / 888.3030)|
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
|• Bone Fixation Screw (FDA Code: HWC / 888.3040)|
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
|• Braces & Collars|
|• Burn Kit|
|• Burn Sheet (FDA Code: FPY / 880.5180)|
A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.
|• Calf Sleeve|
|• Cardiopulmonary Bypass Accessories (FDA Code: KRI / 870.4200)|
Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.
|• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290)|
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
|• Cast Bandage (FDA Code: ITG / 890.3025)|
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
|• Cast Shoe (FDA Code: IPG / 890.3025)|
|• Casting Materials|
|• Casting Materials and Equipment, Casting Stands|
|• Catheter Accessories (FDA Code: KGZ / 878.4200)|
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.