Profile: Trewavis Surgical Instruments Pty Ltd. is a manufacturer of sterile electrosurgical instruments & accessories, biopsy tools and bone wires. Our electrosurgical instruments include monopolar & bipolar forceps, vaginal speculum, needle electrodes and arthroscopy electrodes. Our rectal suction biopsy tool is designed to collect biopsy specimens. The specimens are used in the diagnosis of Hirschsprung's diseases in new-born and young children. Our orthopedic products are Kirschner wires, Steinmann pins and guide wires.
FDA Registration Number: 9680770
US Agent: Bill Sones / Medical Measurements, Inc.
Phone: +1-(201)-489-9400 Fax: +1-(201)-489-5723 E-Mail:
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• 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. |