Profile: Suretek Medical provides surgical reprocessing services. We reprocess a range of single-use devices for hand, arthroscopy, laparoscopy, otolayrngology, gynecology and general surgery. Our frequently reprocessed devices are carpal tunnel blades, orthopedic burs, bits, blades, rasps, reamers, taps, arthroscopic shavers, burs, ENT shavers, bipolar forceps and needle electrodes.
The company is ISO 14971:2000, 11135:1994, 11607-1 certified.
FDA Registration Number: 3005575604
20 Products/Services (Click for related suppliers)
|
| • Arthroscopic Accessories (FDA Code: NBH / 888.1100) An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. |
| • Bone Rasps (FDA Code: HTR / 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. |
| • Bone Taps (FDA Code: HWX / 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. |
| • Compressible Limb Sleeve (FDA Code: JOW / 870.5800) A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. |
| • Disposable Tourniquet Cuffs |
| • Drill Bit (FDA Code: HTW / 888.4540) |
| • General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. |
| • General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
| • Gynecologic Laparoscopic Accessories (FDA Code: NWV / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. |
| • Human Bone Rasps (FDA Code: HTR / 878.4800) |
| • Medical Rasps (FDA Code: HTR / 878.4800) |
| • Monopolar Laparoscopic Scissors |
| • Nose And Throat Ear Bur (FDA Code: EQJ / 874.4140) An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves. |
| • Orthopedic Burr (FDA Code: HTT / 888.4540) |
| • Orthopedic Cannulated Screws |
| • Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
| • Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
| • Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. |
| • Reamer (FDA Code: HTO / 888.4540) |
| • Reprocessed Laparoscopic & Endoscopic Electrosurgical Cutting & Coagulation Accessories (FDA Code: NUJ / 878.4400) |