AUS Systems Pty. Ltd.

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Contact: Paul Zadow - Managing Dir.
Web: http://www.aussystems.com
E-Mail:
Address: 3 Charles Street, Allenby Gardens, SA 5009, Australia
Phone: +61-(8)-8346-6400 | Fax: +61-(8)-8346 6411 | Map/Directions >>

Profile: AUS Systems Pty. Ltd. is a manufacturer & distributor of medical products. Our product area includes suction rectal biopsy systems & titanium plating systems. Our suction rectal biopsy system, rbi2 is used in the diagnosis of Hirschsprung's disease. Our titanium reconstruction plating systems are designed for the treatment of oral maxillo facial surgery, cranio facial surgery, ear, nose & throat surgery, neuro surgery and hand surgery. They offer minimal distortion on post-operative CT scans and MRI investigations.

The company has revenues of < USD 1 Million and is ISO13485 CE certified.

FDA Registration Number: 3005921952
US Agent: Sherry Null / Specialty Surgical Products Inc
Phone: +1-(406)-961-0102 Fax: +1-(406)-961-0103 E-Mail:

2 Products/Services (Click for related suppliers)

• Disposable Surgical Instrument (FDA Code: KDC / 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.

• Suction Biopsy Instrument (FDA Code: FCK / 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.