Mectra Labs, Inc.

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Contact: Thomas P. Clement - VP Sales
Web: http://www.mectralabs.com
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Address: PO Box 350, Two Quality Way, Bloomfield, Indiana 47424, USA
Phone: +1-(812)-384-3521, 800-323-3968 | Fax: +1-(812)-384-8518 | Map/Directions >>

Profile: Mectra Labs, Inc. manufactures medical devices for minimally invasive surgery. We manufacture a wide variety of laparoscopic disposable surgical instruments both as an original equipment manufacturer (OEM) and direct to hospitals. Some of our current products are CO2 patient filter lines, 5mm suction/irrigation (S/I) probes, Laser S/I probes, electro-cautery S/I probes, custom tubing sets for irrigation and/or suction, pneumoperitoneum needles, trocars, electro lube anti-stick solution and custom packaging/sterilization. Our Single Saline™ is an irrigation delivery tube. The luer connects to reusable or disposable valve-controlled probes. Our laparoscopic suction & irrigation probe, NibblitT has push-button control of cutting mechanism comprised of three blades. It is ideal for morcellation and biopsy. It also includes suction and irrigation.

The company was founded in 1988, has revenues of USD 1-5 Million, has ~20 employees and is ISO 9001, CE certified.

FDA Registration Number: 1833052

20 Products/Services (Click for related suppliers)

• Disposable Surgical Instrument (FDA Code: KDC / 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.

• 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.

• 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.

• Endoscope Accessories (FDA Code: KOG)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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.

• General Surgical Instruments

• Instruments surgical

• Irrigation Catheter (FDA Code: GBX / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Irrigation/Evacuation Tube Sets

• Laparoscopic Insufflation Needle

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730)

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

• Laparoscopic Irrigator/Aspirator Suction Probe

• Luers Connector

• Medical Devices

• Monopolar Electrode Cables

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535)

A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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.

• Probes (FDA Code: HXB / 888.4540)

• Suction Tubes

• Trocars