Profile: Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Our cardiovascular instruments includes peripheral vascular, aorta, anastomosis clamps, vascular clips and bulldog clamps, tissue and organ grasping forceps, rib and sternum retractors, valve retractors, microsurgical instruments including scissors, needle holders, forceps, ligation clips, pediatric, and sternum saw. Our columbus knee is a knee implant truly designed for use with computer assisted navigation. Our Safil® Quick is a braided absorbable suture, which provides high initial tensile strength & ultra smooth passage through tissue. Our MonoPlus® is a long-term absorbable monofilament suture made of polydioxanone. MonoPlus gives a great combination of outstanding characteristics, high tensile strength and smooth tissue passage.

The company was founded in 1977, has revenues of USD 1-5 Million, has ~120 employees.

FDA Registration Number: 2916714

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• Rechargeable Replacement Battery (FDA Code: MOQ / 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.

• Rectal Dilator (FDA Code: FFP / 876.5450) A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

• Rectal Speculums

• Rectal Speculums (FDA Code: FFQ / 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.

• Removable Skin Clip (FDA Code: FZQ / 878.4320) A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

• Replacement Suction Tubes

• Resectoscopes (FDA Code: FJL / 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.

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 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.

• Reusable Bipolar Forceps

• Reusable Suture Needle (FDA Code: GDL / 878.4800)

• Reusable Vein Stripper (FDA Code: GAI / 878.4800)

• Rib Rongeurs (FDA Code: HTX / 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.

• Rigid Bronchoscope Biopsy Forceps (FDA Code: JEK / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Rigid Self-Opening Snare (FDA Code: FDJ / 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.

• Ring Cutters (FDA Code: FNS / 880.6200) A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger.

• Rotating Biopsy Punches

• Round Ear Curette

• Rubeola HAI Antiserum (FDA Code: GRG / 866.3520) Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Scalp Clip (FDA Code: HBO / 882.4150) A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Self-Retaining Retractor Systems

• Self-Retaining Retractors (FDA Code: FFO / 876.4730)

• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560) A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Serrated Jaws Carbide Jaw Needle Holder

• Shunt System Implantation Instrument (FDA Code: GYK / 882.4545) A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.

• Silastic Dural Substitute

• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030) Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

• Simple Powered Trephines & Accessories (FDA Code: HBE / 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

• Single use VacutainerT Needle Holder

• Single-Use Needle Holder

• Sinus Cannula (FDA Code: KAM / 878.4800)

• Sinus Endoscopy, Adenoid Curettes

• Sinus Endoscopy, Adenoid Punch

• Sinus Endoscopy, Antrum Punch

• Sinus Endoscopy, Ear Speculums

• Sinus Endoscopy, Ethmoid Punch

• Sinus Endoscopy, Mouth Gag

• Sinus Endoscopy, Nasal Scissors

• Sinus Endoscopy, Needle Holders

• Sinus Irrigator (FDA Code: KAR / 874.4420)

• Sinus Suction Tips

• Sinus Trocar (FDA Code: KBG / 874.4420)

• Skin Graft Surgical Expander (FDA Code: FZW / 878.4800)

• 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.

• Skin Specimen Scraper (FDA Code: LXK / 878.4800)

• Skullplate Screwdriver (FDA Code: GXL / 882.4900) A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.

• Small Kerrison Punches

• 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.