BEUDAMED
    2 results · 19ms · Sources: EU EUDAMED, US FDA

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    TAPES, MEDICAL/SURGICAL - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Batrik Medical Manufacturing Inc.·On the market·6 countries

    NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Corp *·November 16, 2016