Profile: Rema Medizintechnik Gmbh is a developer, manufacturer and distributor of instruments & equipment for endoscopy, arthroscopy, laparoscopy, thoracoscopy, gynecology and urology. The excaliber arthroscope instruments are unbreakable with a high cutting capacity. The wide jaw punch with protective device has good cutting qualities and a finger grip.

The company was founded in 1971, has revenues of USD 5-10 Million, has ~20 employees and is ISO 9000, ISO 9001, CE certified.

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• Abdominal Suction Tube

• Adjustable Suction Tube

• Alligator Jaw-step Biopsy Forceps

• Angled Biopsy Punch

• Arthroscope Accessories

• 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.

• Atraumatic Grasping Forceps

• Automatic Carbon-Dioxide Insufflator (FDA Code: FCX / 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.

• Biliary & Pancreatic Procedures, Biopsy Forceps

• Biopsy Forceps

• Biopsy Forceps Excision

• Biopsy Forceps Femoral Approach

• Biopsy Forceps with Rotating Shafts

• Biopsy Forceps with Two Teeth

• Biopsy Forceps, Internal Jugular Approach

• Biopsy Forceps, Internal Jugular Approach 7

• Biopsy Punch (FDA Code: FCI / 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.

• Biopsy Punch Forceps

• Biopsy Punch Tray

• Biopsy Punches (FDA Code: FCI / 876.1075)

• Bronchoscopic Suction Tubes

• Cardiac Suction Tubes

• Cervical Biopsy Forceps

• Cervical Biopsy Punch

• Circular Dermal Biopsy Punch

• Cleaning, Suction Tube Brush

• Cone Suction Tubes

• Cup Biopsy Forceps

• Dermal Biopsy Punch (FDA Code: FCI / 876.1075)

• Disposable Biopsy Forceps

• Disposable Biopsy Punch

• Disposable Biopsy Punches (FDA Code: FCI / 876.1075)

• Dissecting Biopsy Forceps

• 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 Unipolar Laparoscopy Scissors

• Elliptical Biopsy Punch

• Elliptical Biopsy Punches

• Endoscopic Camera without Audio (FDA Code: FWL / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Endoscopic Light Source

• Endoscopic Video Camera

• Endoscopy, Flexible Biopsy Forceps

• Endoscopy, Hot Biopsy Forceps

• ENT Forceps (FDA Code: KAE / 874.4420)

• Ferguson-Frazier Suction Tubes

• Fiberoptic Cables

• Fiberoptic Light Source & Carrier (FDA Code: EQH / 874.4350) An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

• Flexible Biopsy Forceps

• 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.

• 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 Laparoscope (FDA Code: GCJ / 876.1500)