Scholten Surgical Instruments, Inc.

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Contact: Arie Scholten - CEO
Web: http://www.bioptome.com
E-Mail:
Address: 170 Commerce St. #101, Lodi, California 95240-0722, USA
Phone: +1-(209)-365-1393 | Fax: +1-(209)-365-1437 | Map/Directions >>

Profile: Scholten Surgical Instruments, Inc. provides instruments to safely and effectively take endomyocardial biopsies. Our Scholten disposable Bioptome model called the Novatome™like its predecessors, is specially designed to acquire maximum specimen size for accurate pathology results.

The company was founded in 1979, has revenues of < USD 1 Million and is ISO 9001, ISO 13485 certified.

FDA Registration Number: 2936330

13 Products/Services (Click for related suppliers)

• Autoclaving Plates

• Biopsy Forceps

• 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.

• Endomyocardial Biopsy Forceps

• General & Plastic Surgery Forceps (FDA Code: GEN / 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.

• Myocardial Biopsy Forceps

• Patient Position Support (FDA Code: CCX / 868.6820)

A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.

• Rib Retractor

• Storage Plates

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950)

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Temporary Myocardial Pacemaker Lead