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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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PeriCALM 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
02.08.xx
In Commercial Distribution

  • B087CURVE02081 ()


  • 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
22.01.xx
In Commercial Distribution

  • B087CURV22011 ()


  • 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
21.01.xx
In Commercial Distribution

  • B087CURV21011 ()


  • 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
fastscan.io Intraoral Scanner
Prismatik Dentalcraft, Inc
70-1181-MIL0152
Not in Commercial Distribution

  • D745701181MIL01520 ()
70-1181-MIL0152

  • Dental milling system, CAD/CAM, chairside
fastscan.io Wireless Intraoral Scanner
Prismatik Dentalcraft, Inc
70-1181-MIL0153
Not in Commercial Distribution

  • D745701181MIL01530 ()
70-1181-MIL0153

  • Dental milling system, CAD/CAM, chairside
Primescan Connect OEM Connection Kit short
SIRONA Dental Systems GmbH
6831296
In Commercial Distribution

  • E27668312960 ()
6831296

  • Dental milling system, CAD/CAM, chairside
Primescan Connect OEM Connection Kit long
SIRONA Dental Systems GmbH
6828730
In Commercial Distribution

  • E27668287300 ()
6828730

  • Dental milling system, CAD/CAM, chairside
Primescan Connect OEM Clinician Kit
SIRONA Dental Systems GmbH
6828375
In Commercial Distribution

  • E27668283750 ()
6828375

  • Dental milling system, CAD/CAM, chairside
Omnicam AC B-Ware (refurbished)
SIRONA Dental Systems GmbH
6718857
In Commercial Distribution

  • E27667188570 ()


  • Dental milling system, CAD/CAM, chairside
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