Profile: HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as the implementation of new production methods. Our machinery is regularly updated and always maintained to the most current technical levels. Each manufactured part passes through several control stations during its production process before final inspection is carried out. We fulfill all of the demanding quality requirements established for products in the field of medical technology.

FDA Registration Number: 9611112
US Agent: Dagmar Maeser / Business Support International
Phone: +1-(212)-331-8358  Fax: +1-(212)-257-6441  E-Mail:

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• Self-Retaining Retractors (FDA Code: FFO / 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.

• Skin Marker (FDA Code: FZZ / 878.4660) A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

• Soft Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Surgical Contractor (FDA Code: FZR / 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.

• Surgical Cutter (FDA Code: FZT / 878.4800)

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

• Surgical Knife (FDA Code: EMF / 878.4800)

• Surgical Metal Tongue Depressor (FDA Code: KBL / 874.4420)

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

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• Surgical Skin Markers (FDA Code: FZZ / 878.4660)

• Surgical Stripper (FDA Code: HRT / 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.

• Tonsil Dissector (FDA Code: KBM / 874.4420)

• Tonsil Knife (FDA Code: KBQ / 874.4420)

• Tonsil Snares (FDA Code: KBZ / 874.4420)

• Tonsillectome (FDA Code: KCA / 874.4420)

• Tracheal Dilators (FDA Code: KCG / 874.4420)

• Tracheal Trocar (FDA Code: KCI / 874.4420)

• Traction Head Halter (FDA Code: HSS / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.

• Umbilical Scissors (FDA Code: HDJ / 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:

• Uterine Curettes (FDA Code: HCY / 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:

• Uterine Sounds (FDA Code: HHM / 884.4530)

• Uterine Tenaculum (FDA Code: HDC / 884.4530)

• Wire Loop (FDA Code: JYQ / 874.4420)