Medi-Physics Inc. dba GE Healthcare

  • Adresse du fabricant
    Medi-Physics Inc. dba GE Healthcare, 3350 N Ridge Ave, Arlington Heights IL 60004-1412
  • Société-mère du fabricant (2017)
  • Source
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    product identifier: I125RSRX, Oncura order numbers 85342, 85778, 85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070, 88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom
  • Description du dispositif
    Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. || RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.