Device Recall Mermaid Medical MBiopsy Coaxial Introducer Needle

  • Model / Serial
    Lot No: P000290, P000360, P000230, P000291, P000299, P000148 Catalogue No: N20314010- N20320020 (for PRO-MAG Biopsy Instrument) Catalogue No: N20414010- N20420020 (for MAGNUM Biopsy Instrument)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to FL including PR.
  • Product Description
    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a || white carton unit box. || The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mermaid Medical A/S, Frydensbergvej 25, Stenl?se Denmark
  • Manufacturer Parent Company (2017)
  • Source
    USFDA