Guenter Stoffel Medizintechnik Gmbh

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Contact: Dieter Stoffel
Web: http://www.insto.de
E-Mail:
Address: Kantstr. 37, Wurmlingen D-78573, Germany
Phone: +49-(7461)-5890 | Fax: +49-(7461)-78730 | Map/Directions >>

Profile: Guenter Stoffel Medizintechnik Gmbh offers instruments for micro-surgery and endoscopy. Our product line includes biopsy forceps, scissors, tweezers, needle & blade holders, flexible endoscopy biopsy & flexible foreign body forceps.

The company is ISO 13485, CE mark certified.

FDA Registration Number: 8010370
US Agent: Franz Menean / Medagent, Inc.
Phone: +1-(603)-570-2039 Fax: +1-(603)-570-2055 E-Mail:

18 Products/Services (Click for related suppliers)

• Bone Clamp (FDA Code: HXD / 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.

• 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.

• Endomyocardial Biopsy Device (FDA Code: DWZ / 870.4075)

An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

• ENT Forceps (FDA Code: KAE / 874.4420)

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730)

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

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

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 884.4520)

An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

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

• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530)

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Hemostats (FDA Code: HRQ / 878.4800)

• Manual Gastro-Urology Surgical Instrument (FDA Code: KOA / 876.4730)

• Microsurgical Instruments (FDA Code: GZX / 882.4525)

A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Non-Electric Biopsy Forceps (FDA Code: FCL / 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.

• 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.

• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)

• Scalpel Blade (FDA Code: GES / 878.4800)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)