Amplatzer Delivery System

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP

15 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model Catalog: 9-DEL-10F-45/80 (Lot serial: N/A)
  • Description du dispositif
    AMPLATZER DELIVERY SYSTEM
  • Manufacturer
  • Modèle / numéro de série
    00E01-13, M02K07-44, M03C24-17, M03E27-07, M03F18-09, M03L11-45, M04B09-16, M04E27-19
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Description du dispositif
    Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchang Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modèle / numéro de série
    M01J08-12, M02D26-01, M02L11-20, M03A09-12, M03B20-12, M03D16-24, M03F18-08, M03L12-09, M04C23-09, M04G01-24
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Description du dispositif
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modèle / numéro de série
    M01K01-6, M02C12-24, M02C25-15, M02F05-23, M02F24-05, M02L02-21, M03A09-10, M03A09-15, M03A20-10, M03B20-17 M03C24-14, M03F02-17, M03G23-08, M03H12-42, M03J19-07 M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14 M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23 M04H03-23, M04J17-07, M04K07-02
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Description du dispositif
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modèle / numéro de série
    M02D26-02, M02I23-02, M02J10-09, M02K07-47, M03C04-06 M03D16-16, M03F18-07, M03K14-07, M03L18-50, M03M03-11 M04C23-10, M04E24-18, M04G01-20
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Description du dispositif
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
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