Profile: Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosurgery, laser surgery, and dental surgery. Our surgicam comes in a modular and flexible design. Our maxium® offers a bipolar cut and coagulation mode for bipolar resection.

The company has revenues of < USD 1 Million, has ~700 employees and is ISO 9001, CE certified.

FDA Registration Number: 8010168
US Agent: Angelika Scherp / Business Support International
Phone: +1-(212)-331-8358  Fax: +1-(212)-257-6441  E-Mail: infobsi-fda.com

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• Ear Rasp (FDA Code: JYY / 874.4420)

• Ear Scissors (FDA Code: JZB / 874.4420)

• Ear Snare (FDA Code: JZD / 874.4420)

• Ear Spoon (FDA Code: JZE / 874.4420)

• Ear Spoon & Hook

• Ear Suction Tube (FDA Code: JZF / 874.4420)

• Ear-Lobe Perforator (FDA Code: JYS / 874.4420)

• 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.

• Electrical Rigid Sigmoidoscope (FDA Code: FAN / 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.

• Electrically Powered Saw (FDA Code: DWI / 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.

• Electrosurgical and Coagulation Unit with Accessories (FDA Code: BWA / 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 Apparatus (FDA Code: HAM / 878.4400)

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

• Electrosurgical Devices (FDA Code: DWG / 878.4400)

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Eletric/Pneumatic ENT Surgical Saw (FDA Code: EWQ / 874.4420)

• Elliptical Biopsy Punch

• Elliptical Biopsy Punches

• Endoscope Electric Cord (FDA Code: FFZ / 876.1500)

• Endoscope Transformer (FDA Code: GCW / 876.1500)

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

• Endoscopic Obturator (FDA Code: FEC / 876.1500)

• Endoscopic Video Camera

• Endotracheal Tubes & Accessories, Laryngectomy Tubes

• ENT Atomizer and Tip

• ENT Bite Block

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Headlight

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Nasal Gouge (FDA Code: KAQ / 874.4420)

• ENT Powder Blower (FDA Code: KCL / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Tracheal Hook (FDA Code: KCH / 874.4420)

• ENT Tuning Fork

• Episiotomy Scissors (FDA Code: HDK / 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:

• Ethmoid Curettes (FDA Code: KAO / 874.4420)

• Ethmoid Punch (FDA Code: KAX / 874.4420)

• Eustachian Bougie (FDA Code: KBI / 874.4175) A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

• Examination (Light) Lamp

• Extended Disposable Needle Electrode

• Female Urethral Catheterization Kit

• Fiberoptic Focusing Headlight (FDA Code: FCT / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• Flexible Suction Coagulator Electrode (FDA Code: FEH / 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.

• Forceps (FDA Code: HTD / 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.

• Forceps Needle Holders

• Frazier Suction Tip

• Frontal-Sinus Rasp (FDA Code: KAZ / 874.4420)

• Gastro-Urology and Gastrointestinal Esophageal Bougie (FDA Code: FAT / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).