Hart Enterprises, Inc.

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Contact: Larry Swan - Director of Marketing & Sales
Web: http://www.hartneedles.com
E-Mail:
Address: 400 Applejack Ct., Sparta, Michigan 49345, USA
Phone: +1-(616)-887-0400 | Fax: +1-(616)-887-5400 | Map/Directions >>

Profile: Hart Enterprises, Inc. offers medical products such as guidewire introducers, biopsy needles and spinal needles. The Chiba biopsy needle is a fine-needle percutaneous, soft-tissue, aspiration biopsy instrument. Its interlocking hub and cap yield low trauma. It is also utilized for injection of radiopaque dyes. Our Franseen style biopsy needle has a trocar pointed stylet and a serrated outer needle that assists in the placement of the needle and removal of lung tissue.

The company was founded in 1976, has revenues of USD 5-10 Million, has ~80 employees.

FDA Registration Number: 1828424

16 Products/Services (Click for related suppliers)

• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150)

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

• 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)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Cannulas

• Cardiovascular Biopsy Needle (FDA Code: DWO / 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.

• Catheter Introducers (FDA Code: DYB / 870.1340)

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Needle (FDA Code: GCB / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Cholangiography Catheters (FDA Code: GBZ / 878.4200)

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

• Guide Wire Introducer Needles

• Hypodermic Needles

• Packaging

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800)

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Spinal Needles