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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
AMI Agency for Medical Innovations GmbH
RAR2081
In Commercial Distribution

  • EAMIRAR20810 ()
  • EAMIRAR20811 ()

  • Length: 97 Millimeter
  • Outer Diameter: 30 Millimeter
RAR2081

  • Noninvasive vascular ultrasound system
No Description
AMI Agency for Medical Innovations GmbH
RAR 2011
Not in Commercial Distribution

  • EAMIRAR20110 ()
  • EAMIRAR20111 ()
RAR 2011

  • Noninvasive vascular ultrasound system
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5531
In Commercial Distribution

  • EAMIMCS55311 ()
  • EAMIMCS55310 ()
MCS5531

  • Tissue extraction bag
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5511
In Commercial Distribution

  • EAMIMCS55110 ()
  • MCS55111 ()
MCS5511

  • Tissue extraction bag
FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.
AMI Agency for Medical Innovations GmbH
FIX2001
In Commercial Distribution

  • EAMIFIX20011 ()
  • EAMIFIX20010 ()
FIX2001

  • Anal fistula circular cutter
No Description
AMI Agency for Medical Innovations GmbH
EVI1011
Not in Commercial Distribution

  • EAMIEVI10111 ()
  • EAMIEVI10110 ()

  • Outer Diameter: 5 Millimeter
  • Length: 45 Millimeter
EVI1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
ESM1011
Not in Commercial Distribution

  • EAMIESM10111 ()
  • EAMIESM10110 ()

  • Outer Diameter: 3 Millimeter
  • Length: 21 Millimeter
ESM1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
ESI1210
Not in Commercial Distribution

  • EAMIESI12101 ()
  • EAMIESI12100 ()
ESI1210

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1151
Not in Commercial Distribution

  • EAMIESI11511 ()
  • EAMIESI11510 ()

  • Outer Diameter: 5 Millimeter
  • Length: 33 Millimeter
ESI1151

  • Endoscopic electrosurgical electrode, monopolar, single-use
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