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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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iTero Element 5D Upgrade kit Laptop Configuration - 00816063020578

Scanner Upgrade Kit
Align Technology, Inc.
206856
In Commercial Distribution

  • 00816063020578 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D Upgrade kit - 00816063020561

Scanner Upgrade Kit
Align Technology, Inc.
206855
In Commercial Distribution

  • 00816063020561 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D Laptop Configuration - 00816063020509

Scanner
Align Technology, Inc.
206160
In Commercial Distribution

  • 00816063020509 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D - 00816063020493

Scanner
Align Technology, Inc.
205929
In Commercial Distribution

  • 00816063020493 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element Flex - 00816063020295

Scanner
Align Technology, Inc.
202964
In Commercial Distribution

  • 00816063020295 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 2 - 00816063020288

No Description
Align Technology, Inc.
202965
In Commercial Distribution

  • 00816063020288 ()


  • Dental milling system, CAD/CAM, chairside

Itero Element - 00816063020141

Scanner
Align Technology, Inc.
108064
In Commercial Distribution

  • 00816063020141 ()


  • Dental milling system, CAD/CAM, chairside

Itero Element - 00816063020134

Scanner
Align Technology, Inc.
108063
In Commercial Distribution

  • 00816063020134 ()


  • Dental milling system, CAD/CAM, chairside

PeriWatch Vigilance® Cues™ - B087PATT202421

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087PATT202421 ()


  • Obstetrical monitoring/analysis software

PeriWatch Vigilance® Cues™ - B087PATT202411

PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087PATT202411 ()


  • Obstetrical monitoring/analysis software
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