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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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DI for Perceval Size XL
CORCYM SRL
PVS27
In Commercial Distribution

  • 08022057014726 ()
PVS27

  • Aortic open-surgery heart valve bioprosthesis
DI for Perceval Size L
CORCYM SRL
PVS25
In Commercial Distribution

  • 08022057014719 ()
PVS25

  • Aortic open-surgery heart valve bioprosthesis
DI for Perceval Size M
CORCYM SRL
PVS23
In Commercial Distribution

  • 08022057014702 ()
PVS23

  • Aortic open-surgery heart valve bioprosthesis
DI for Perceval Size S
CORCYM SRL
PVS21
In Commercial Distribution

  • 08022057014696 ()
PVS21

  • Aortic open-surgery heart valve bioprosthesis
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
RESHAPE MEDICAL, INC.
RSM110
Not in Commercial Distribution

  • B001RSM1101 ()
RSM110

  • Appetite-suppression gastric balloon
IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
RESHAPE MEDICAL, INC.
RSM101
Not in Commercial Distribution

  • B001RSM1011 ()
RSM101

  • Appetite-suppression gastric balloon
Footswitch for Sentimag Gen 3
ENDOMAGNETICS LTD
Gen 3 Footswitch
In Commercial Distribution

  • 15060391210336 ()
SMA03

  • Magnetic metal detector
spare screws for neuro stereotactic frame for use during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame Screws Set
In Commercial Distribution

  • 07290015461313 ()
MPR001138

  • Therapeutic oncological/gynaecological ultrasound system
Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator
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