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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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BD 09 L 20
NOVATECH
02841
In Commercial Distribution

  • EBES028410 ()
  • EBES028411 ()
02841

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 12 L 10 to 60
NOVATECH
026951
In Commercial Distribution

  • EBES0269510 ()
  • EBES0269511 ()
026951

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 11 L 10 to 60
NOVATECH
026901
Not in Commercial Distribution

  • EBES0269010 ()
  • EBES0269011 ()
026901

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 10 L 10 to 60
NOVATECH
026801
Not in Commercial Distribution

  • EBES0268010 ()
  • EBES0268011 ()
026801

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 09 L 10 to 60
NOVATECH
026751
Not in Commercial Distribution

  • EBES0267510 ()
  • EBES0267511 ()
026751

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 7X8 L 10 to 50
NOVATECH
026701
Not in Commercial Distribution

  • EBES0267010 ()
  • EBES0267011 ()
026701

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 6X7 L 10 to 50
NOVATECH
026501
Not in Commercial Distribution

  • EBES0265010 ()
  • EBES0265011 ()
026501

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 5X6 L 10 to 50
NOVATECH
026201
Not in Commercial Distribution

  • EBES0262010 ()
  • EBES0262011 ()
026201

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BB 4X5 L 10 to 50
NOVATECH
025301
Not in Commercial Distribution

  • EBES0253010 ()
  • EBES0253011 ()
025301

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
Bag for retrieving specimen for 5 mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI1031
Not in Commercial Distribution

  • EAMITBI10310 ()
  • EAMITBI10311 ()

  • Length: 515 Millimeter
TBI1031

  • Tissue extraction bag
Bag for retrieving specimen for 10mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI1021
Not in Commercial Distribution

  • EAMITBI10210 ()
  • EAMITBI10211 ()

  • Length: 485 Millimeter
TBI1021

  • Tissue extraction bag
Mag for retrieving speciment for 10 mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.fsing.
AMI Agency for Medical Innovations GmbH
TBI1011
Not in Commercial Distribution

  • EAMITBI10110 ()
  • EAMITBI10111 ()

  • Length: 515 Millimeter
TBI1011

  • Tissue extraction bag
Bag for retrieving specimen. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI 100
Not in Commercial Distribution

  • EAMITBI1000 ()
  • EAMITBI1001 ()

  • Length: 485 Millimeter
TBI 100

  • Tissue extraction bag
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
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