Profile: Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan® single-use aorta/vein punches have large finger rings for greater control & accuracy and tapered tips for an unobstructed view of the operating field. It has features such as tapered tip, unique elliptical sizes and is radiopaque. Our titanium micro clamps are handcrafted and are available in a wide variety of angled shanks & jaw configurations. It s advantages are light- weight, durability, atraumatic nature and superior strength.

The company was founded in 1921, has revenues of USD 1-5 Million, has ~30 employees and is ISO 9001, CE certified.

FDA Registration Number: 2126670

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• Delicate Tissue Forceps

• Device Label

• 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.

• Disposable Aortic Punch

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

• Disposable Bulldog Clamps

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

• Disposable Microscissors: Vertical

• Disposable Sterile Umbilical Cord Clamps

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)

• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Dressing and Tissue Forceps

• 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.

• Electrosurgery, Tissue 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.

• Endoscopic Bowel Bulldog Clamp

• Endoscopic Vascular Bulldog Clamp

• Endovascular Dilator Set

• Enucleation Scissors Slightly Curved

• Forceps (FDA Code: HTD / 878.4800)

• Forceps Needle Holders

• 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 Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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.

• General & Plastic Surgery Mirror (FDA Code: FTX / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hemostatic Forceps

• Hexagonal Needle Holder

• Horizontal Curved Microscissors

• Horizontal Scissors

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Intestinal Tissue Forceps

• Intraluminal Artery Stripper (FDA Code: DWX / 870.4875) An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Iris Tissue Forceps

• LEEP Tissue Forceps

• Left Hand Needle Holders

• Left-handed Halsted-Mosquito. Hemostatic Forceps

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

• Lung Grasping Tissue Forceps

• Mammary Retractor

• Manual Surgical Instrument

• Mayo Tungsten Carbide Operating Scissors

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Skull Clamps

• Micro Bulldog Clamps