Profile: Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing products, oxygen regulator and diabetic care products. We provide gloves in small, large and extra large sizes for medical use. Our diabetic care products include glucose monitor kits and glucose test strips. We also provide surgical instruments such as bone plasters, diagnostics, ear instruments, forceps, needles & probes, scissors, sponge and needle holders.

FDA Registration Number: 1062671

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• Percussor, Vibrator (FDA Code: GWZ / 882.1700) A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.

• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Reservoir Bag (FDA Code: BTC / 868.5320) A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

• Reusable Hot /Cold Pack (FDA Code: IME / 890.5700) A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.

• Reusable Hot and Cold Gel Packs

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Ring Cutters (FDA Code: FNS / 880.6200) A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger.

• Sharpes Container (FDA Code: MMK / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Single Head Stethoscope

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)

• 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 Protectant Liquid Bandage (FDA Code: NEC / 880.5090) A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

• Sphygmomanometers

• Splints

• 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 Arm Board with Cover (FDA Code: BTX / 878.3910) A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• 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 Specimen Trap (FDA Code: BYZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Stethoscopes

• Suction Catheter and Tip (FDA Code: JOL / 880.6740)

• 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 Caps (FDA Code: FYF / 878.4040)

• Surgical Instrument Tray (FDA Code: FSM / 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.

• Surgical Isolation Gown (FDA Code: FYC / 878.4040)

• Surgical Masks (FDA Code: FXX / 878.4040)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Surgical Razor (FDA Code: LWK / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Suture Removal Kit (FDA Code: MCZ / 878.4800)

• Table Operating Room Accessories (FDA Code: FWZ / 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.

• Tee Drain/Water Trap (FDA Code: BYH / 868.5995) A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.

• Tongue Depressors (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.

• Towels & Wipes

• Tracheal Tube Cleaning Brushes (FDA Code: EPE / 868.5795) A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.

• Tracheal Tube Fixation Device (FDA Code: CBH / 868.5770) A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.

• Tracheal Tube Stylet (FDA Code: BSR / 868.5790) A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

• Tracheal Tube with/without Connector (FDA Code: BTR / 868.5730) A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810) A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

• Tracheostomy Tube with/without Connector (FDA Code: BTO / 868.5800) A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

• Traction Splint (FDA Code: HSP / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

• Transfer Aid (FDA Code: IKX / 890.5050) A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.

• Transfer Aid for Disabled/Handicapped (FDA Code: IKX / 890.5050)

• Tuning Forks (FDA Code: GWX / 882.1525) A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

• Umbilical Occlusion Device (FDA Code: FOD / 880.5950) An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.

• Unscented Menstrual Pad (FDA Code: HHD / 884.5435) An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

• Ureteral Catheter Holder (FDA Code: EYJ / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Urinary Drainage Collection Kit (FDA Code: FCN / 876.5250)