Intact Medical Corporation

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Contact: Douglas Macarthur
Web: http://www.intactmedical.com
E-Mail:
Address: One Apple Hill Suite 316, Natick, Massachusetts 01760, USA
Phone: +1-(508)-6557820, 888-430-4490 | Map/Directions >>

Profile: Intact Medical Corporation provides minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications. Our Intact™ breast lesion excision system (BLES) captures breast tissue for histological review, using RF energy. The Intact™ BLES is able to deliver a sample with intact architecture and clear margins around the area of interest, in a swift, in-office procedure.

8 Products/Services (Click for related suppliers)

• Biopsy Instruments (FDA Code: KNW / 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 Instruments (FDA Code: KNW / 876.1075)

• Breast Lesion Excision Systems

• 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.

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300)

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Implantable Staple (FDA Code: GDW / 878.4750)

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Surgical Retractor (FDA Code: GAD / 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.

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