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Sterilmed, Inc.

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Web: http://www.sterilmed.com
E-Mail:
Address: 11400 73rd Ave. North, #100, Maple Grove, Minnesota 55369, USA
Phone: +1-(763)-488-3400, 888-252-1542 | Fax: +1-(763)-488-3350 | Map/Directions >>
 
 

Profile: Sterilmed, Inc. offers reprocessing, repair, and refurbishment of medical devices, equipment, and instruments. We also specialize in the sale of quality pre-owned surgical video equipment. Our pre-owned equipment has been thoroughly inspected, refurbished and tested to meet manufacturer's specifications. Our pre-owned equipment include power equipment, cameras, surgical video equipment, endoscopes, and rigid endoscopes.

FDA Registration Number: 2134070

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• Anesthesiology Oropharyngeal Airway (FDA Code: CAE / 868.5110)
An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
• 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)
• Arthroscopic Shavers
• Arthroscopy, Hook Probe
• 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.
• Balloon Inflation Devices
• Bed Patient Monitor (FDA Code: KMI / 880.2400)
A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.
• Biopsy Forceps
• 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.
• Burr
• Burs & Drills
• Cartilage Knives
• Chest Retractors
• Chisels
• 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.
• Diagnostic Catheter
• Disposable Tourniquet Cuffs
• Drill Bit (FDA Code: HTW / 888.4540)
• Electric ENT Surgical Drill (FDA Code: ERL / 874.4250)
An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.
• Electrode Cables (FDA Code: IKD / 890.1175)
An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
• Electrophysiology Diagnostic Catheters
• 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.
• Electrosurgical Electrode (FDA Code: JOS / 878.4400)
• Endoscope Cleaning Brushes & Accessories (FDA Code: MNL / 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.
• Endoscopic Bite Blocks (FDA Code: MNK / 876.1500)
• Endoscopic Electrode
• Endoscopic Trocars
• Fiberoptic Retractor (FDA Code: FDG / 876.4530)
A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.
• 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 & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)
• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)
• Guidewires
• Heart Stabilizer (FDA Code: MWS / 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.
• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)
• Laparoscopic Trocar
• Laser Power Probe
• Manual Surgical Chisel (FDA Code: FZO / 878.4800)
• Mask
• Medical Rasps (FDA Code: HTR / 878.4800)
• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680)
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.
• Metallic Threaded Fixation Pin (FDA Code: NDM / 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.
• Modular Laparoscopic Instruments
• Multiple Component Fixation Appliance (FDA Code: KTT / 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.
• Ophthalmic Lasers (FDA Code: HQF / 886.4390)
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
• Orthopedic Rasps
• Oxygen Masks (FDA Code: BYG / 868.5580)
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
• 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.
• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810)
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

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