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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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Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978015 ()


  • Hand-held ultrasound imaging system, body-surface
Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978008 ()


  • Hand-held ultrasound imaging system, body-surface
COR-KNOT® MICRO Twin Pack
LSI Solutions, Inc.
032760
In Commercial Distribution

  • 10850012846427 ()
  • 00850012846420 ()
  • 00850012846444 ()
032760

  • Suture clasp, non-bioabsorbable
VIRTUOSEW™ DEVICE
LSI Solutions, Inc.
023050
In Commercial Distribution

  • 10850012846281 ()
  • 00850012846284 ()
023050

  • Suturing unit, single-use
MD™ QUICK LOAD® SUTURE (2-0 Polyester, Green, Non-absorbable, 38") with Needle Cap Unloader
LSI Solutions, Inc.
023160
In Commercial Distribution

  • 10850012846243 ()
  • 00850012846246 ()

  • Length: 38 Inch
023160

  • Polyester suture, non-bioabsorbable, multifilament
Mi-CHORD™ SYSTEM
LSI Solutions, Inc.
032150
In Commercial Distribution

  • 10850012846045 ()
  • 00850012846048 ()
032150

  • Suturing unit, single-use
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-40
In Commercial Distribution

  • 00837654070956 ()
  • 00850012832546 ()
  • 00850012832553 ()

  • Total Volume: 40 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-35
In Commercial Distribution

  • 00837654076415 ()
  • 00850012832515 ()
  • 00850012832522 ()

  • Total Volume: 35 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-30
In Commercial Distribution

  • 00837654076439 ()
  • 00850012832485 ()
  • 00850012832492 ()

  • Catheter Gauge: 7 French
  • Total Volume: 30 Milliliter


  • Intra-aortic balloon catheter
The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.
INSIGHTRA MEDICAL, INC.
FVHR35X45
In Commercial Distribution

  • 00850012832348 ()
  • 00013964672008 ()
  • 00850012832355 ()

  • 35X45
FVHR35X45

  • Extra-gynaecological surgical mesh, composite-polymer
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