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Lesion-Loc I-125 Seed/Needle is indication of lesions (as shown by mamnogram or ultrasound) in the breast or other tissue under the direct supervision of a qualified physician. The device is "single-use sterile device". Lesion-Loc I-125 Seed/needle is not intended for permanant implantation and should be removed in a few days after implantation. It us to be used in conjunction with the Gammaprobe® (IntraMedical Imaging) for localization of lesions (as shown by a mammogram or ultrasound images) in the breast and other tissues. The Lesion-Loc I-125 Seed/Needle is intended for clinical use in the marking of lesions with the seed in close proximity to or within the lesion site. The lesion (as seen in a mammogram or ultrasound image) is then located using an appropriate hand held gamma radiation detector.

Lesion-Loc I-125 Seed/Needle contains a source 4.5 mm long and 0.8 mm in diameter. The source consists of a welded titanium capsule with a 0.05 mm thick wall and a silver rod, which is about 4 mm length with the active material as silver iodide on the surface, welded inside the titanium capsule. The seed is contained in a needle. The needles used are standard 18 gauges available commercially in lengths up to 15 cm. The I-125 seed is loaded inside the needle. The radioactive seeds are introduced into the lesion area as directed by a radiologist per Written Directive and prescription. The devices are packaged in a pouch with label and provided sterile.