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

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• Skin Pressure Protector (FDA Code: FMP / 880.6450) A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).

• Skin Staplers & Removers

• Slimline Knee Brace

• Splints

• Sponges

• Sport Wheelchairs

• Stack Finger Splints

• Stainless Steel Medicine Cup

• Stainless Steel Needle Holders

• Standard Needle Holders

• Standard Surgical Skin Markers

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Sterile Gauze

• Sterile Label/Tag (FDA Code: LYV / 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.

• Sterile Medical Grade Casting Material

• Sterile Procedure Trays

• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Sterilization Wrap Containers (FDA Code: KCT / 880.6850)

• Sterilizers & Autoclaves

• Stockinette

• Stopcock, I.V.Set (FDA Code: FMG / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Straight Carbide Jaw Needle Holder

• Straps, Slings & Immobilizers

• Suction Canister Systems

• Surgical Apparel Accessories (FDA Code: LYU / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Gowns (FDA Code: FYA / 878.4040)

• Surgical Incision Drape

• Surgical Instrument Container

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Light Accessories (FDA Code: FTA / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

• Surgical Procedure Trays

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Scalpels

• Surgical Skin Markers (FDA Code: FZZ / 878.4660) A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

• Surgical Snare (FDA Code: GAE / 878.4800)

• Surgical Sponge Counter (FDA Code: LWH / 880.2740) A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

• Surgical Staplers, Circular Staplers

• Surgical Staplers, Laparoscopic Staplers

• Surgical Staplers, Open Clip Appliers

• Surgical Staplers, Stainless Steel Staples

• Surgical Staplers, Titanium Staples

• Surgical Table Cushion (FDA Code: LWG / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Surgical Trays (FDA Code: LRP / 878.4800)