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Aesculap Inc.

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Web: http://www.aesculapusa.com
E-Mail:
Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
Phone: +1-(800)-258-1946 | Fax: +1-(610)-791-6880 | Map/Directions >>
 
 

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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• Diagnostic Spirometer (FDA Code: BZG / 868.1840)
A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
• Diagnostic/Surgical Loupe (FDA Code: FSP / 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.
• Disconnect Forceps (FDA Code: FJR / 876.5540)
A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.
• Disposable Adenoid Curettes
• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)
• Disposable Biopsy Punch
• Disposable Biopsy Punches (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.
• Disposable Ear Curette
• Disposable Microscissors
• Disposable Surgical Drape (FDA Code: KKX / 878.4370)
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
• Disposable Vein Stripper (FDA Code: GAJ / 878.4800)
• Double-Ended Disposable Ear Curettes
• Drill Bit (FDA Code: HTW / 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.
• Drill Brace (FDA Code: HXY / 888.4540)
• Drills
• Drills Accessories
• Dura-Substitute (FDA Code: GXQ / 882.5910)
A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
• Dural Substitute
• Ear Cannula (FDA Code: JYC / 878.4800)
• Ear Curette (FDA Code: JYG / 874.4420)
• Ear Excavator (FDA Code: JYH / 874.4420)
• Ear Knife (FDA Code: JYO / 874.4420)
• Ear Micro Curettes
• Ear Rasp (FDA Code: JYY / 874.4420)
• Ear Scissors (FDA Code: JZB / 874.4420)
• Ear Snare (FDA Code: JZD / 874.4420)
• 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.
• Ear Speculum Holder (FDA Code: JYK / 878.1800)
• Ear Spoon (FDA Code: JZE / 874.4420)
• Ear Spoon & Hook
• Ear Suction Tube (FDA Code: JZF / 874.4420)
• Ear Syringes Repair Service
• Echinococcus SPP Agglutinating Antigen (FDA Code: GPF / 866.3200)
• Electric Drill Motor (FDA Code: HBC / 882.4360)
An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.
• Electric Ear Syringe
• Electrical Power Accessories
• 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 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.
• Eletric/Pneumatic ENT Surgical Saw (FDA Code: EWQ / 874.4420)
• Elliptical Biopsy Punch
• Elliptical Biopsy Punches
• Emesis Basin (FDA Code: FNY / 880.6730)
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
• 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.
• Endoscope Accessories (FDA Code: KOG)
• Endoscopes
• Endoscopic Cleaning Accessories (FDA Code: FEB / 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.
• Endoscopic Mirror (FDA Code: GCO / 876.1500)
• Endoscopic Obturator (FDA Code: FEC / 876.1500)
• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500)
• Endoscopic Repair Service

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