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SeeDOS code 0705- 01 : 1 Marker / 1 Needle per pouch. 10 sterile pouches per box SeeDOS code 0705- 03 : 3 Markers / 3 Needles per pouch. 10 sterile pouches per box  GO to Gold Fiduciary Markers Quotation Request form HOW SUPPLIED: The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide. INSTRUCTIONS FOR USE · Carefully remove the "sterile" Mick® Gold Fiduciary Marker needle from the sterile pouch, · Remove the plastic protective sheath from the needle, · Insert the sterile needle into the desired anatomical location being careful NOT to dislodge or move the stylet, · Once placed correctly, remove the white stopper from the stylet; push laterally on the white paddle and pull it off the stylet, · Hold the needle steady and push the blue stylet handle forward to stop and eject the marker, · Remove the needle slowly and with caution; removing the needle too quickly may result in marker displacement, · Discard of the needle in appropriate sharps disposal containers or by standard hospital sharps disposal procedures. SPECIFICATIONS PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS Sterile, biocompatible interstitial needles each containing a solid gold marker. GOLD MARKER SIZE: 1.2mm dia x 3.0mm DESCRIPTION: Mick® Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker loaded into a standard 17 gauge brachytherapy needle that has been pre-plugged with CP Bone Wax. The patient contacting parts of the needle are made of 304 stainless steel. The markers are cast from solid gold (99.99% purity). INDICATIONS: The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy. CONTRAINDICATIONS There are no known contraindications for using brachytherapy needles or for the implanted gold markers. WARNINGS and PRECAUTIONS: A WARNING indicates the potential for death, serious injury, or other serious adverse events due to use or misuse of the device. · This product may only be used by a qualified health care professional. · Single use only - DO NOT reuse · DO NOT re-sterilize · DO NOT use if sterile package is damaged · DO NOT use damaged product A CAUTION indicates the potential to damage the device as a result of use or misuse of the device. · Before use, inspect the sterile package for seal integrity and other damage that may affect product sterility. · Verify the product expiration date has not been exceeded. · Use aseptic procedures to remove the needle(s) from the package. |
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