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The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.

The IsoAid I-125 Radioactive Seed Localization Needle [IA-RSLN] is a pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed [K011205]. The needle tip is occluded with bone wax to contain the contents prior to implant. The iodine seed is loaded loose or stranded and is provided with or without trailing spacers. The stainless steel needles are provided in lengths: 5cm, 7cm, and 12cm. The device is used to facilitate the introduction of the radionuclide seed into the suspicious tissue. The seed is used singly as a point-source for localization rather than for therapeutic use as in brachytherapy. The device is packaged and labeled and EtO sterilized.

The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The ISOAID Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.