Profile: Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usable surgical devices & a growing number of devices that have traditionally been considered disposable (or single use) at half the original purchase cost on average. Our protocols ensure that the devices meet the highest standards in terms of quality, functionality and safety before being returned to the concerned facility.

FDA Registration Number: 3032391

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• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 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.

• Arthroscopes (FDA Code: HRX / 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.

• Arthroscopic Accessories (FDA Code: NBH / 888.1100)

• 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.

• Bone Rasps (FDA Code: HTR / 878.4800)

• Bone Staple Driver (FDA Code: HXJ / 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.

• Bone Taps (FDA Code: HWX / 888.4540)

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 878.4820)

• 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.

• Drill Bit (FDA Code: HTW / 888.4540)

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)

• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Instrument Cleaning System

• Instrument Maintenance & Refurbishing Service

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Devices

• Medical Rasps (FDA Code: HTR / 878.4800)

• Nasal Knife (FDA Code: KAS / 874.4420)

• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850) A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

• One-Piece Scalpel (FDA Code: GDX / 878.4800)

• Orthopedic Burr (FDA Code: HTT / 888.4540)

• Orthopedic Knife (FDA Code: HTS / 888.4540)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Orthopedic Osteotome (FDA Code: HWM / 878.4800)

• Packaging

• 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.

• Pneumatic-Powered Surgical Instrument Motor (FDA Code: GET / 878.4820)

• Reamer (FDA Code: HTO / 888.4540)

• Reprocessed Electric Biopsy Forceps (FDA Code: NLU / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Reprocessed General & Plastic Surgery Laparoscope (FDA Code: NLM / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Reprocessed Non-Electric Biopsy Forceps (FDA Code: NON / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Reprocessed Phacoemulsification Needle (FDA Code: NKX / 886.4670) A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

• Reprocessed Ultrasonic Scalpel (FDA Code: NLQ)

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Stomach and Intestinal Suture Apparatus (FDA Code: FHM / 878.4800)

• Surgical Cutter (FDA Code: FZT / 878.4800)

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• Surgical Snare (FDA Code: GAE / 878.4800)

• Surgical Staple Applier (FDA Code: GEF / 878.4800)