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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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PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2025.1.xxx
In Commercial Distribution

  • B087CURV202511 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087CURV202421 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087CURV202411 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2022.2.xxx
In Commercial Distribution

  • B087CURV202221 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
02.12.xx
In Commercial Distribution

  • B087CURV02121 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.10.xx
In Commercial Distribution

  • B087CURV02101 ()


  • Obstetrical monitoring/analysis software
50mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD6
In Commercial Distribution

  • 1111096 ()
  • M364111109FD6 ()

  • Outer Diameter: 9 Millimeter
  • Length: 50 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
45mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD5
In Commercial Distribution

  • 1111095 ()
  • M364111109FD50 ()

  • Outer Diameter: 9 Millimeter
  • Length: 45 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
40mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD4
In Commercial Distribution

  • 1111094 ()
  • M364111109FD40 ()

  • Outer Diameter: 9 Millimeter
  • Length: 40 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD3
In Commercial Distribution

  • 1111093 ()
  • M364111109FD30 ()

  • Outer Diameter: 9 Millimeter
  • Length: 35 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
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