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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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Packed 5D Plus Scanning Unit, RMA - 00816063021001

Packed 5D Plus Scanning Unit, RMA
Align Technology, Inc.
212260
In Commercial Distribution

  • 00816063021001 ()


  • Dental milling system, CAD/CAM, chairside

Packed Element Plus Scanning Unit, RMA - 00816063020998

Wand RMAs
Align Technology, Inc.
211889
In Commercial Distribution

  • 00816063020998 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element Plus wheel stand, service - 00816063020981

WS service
Align Technology, Inc.
211563
In Commercial Distribution

  • 00816063020981 ()


  • Dental milling system, CAD/CAM, chairside

iTero 5D Scanning Unit - 00816063020875

Scanning unit
Align Technology, Inc.
211871
In Commercial Distribution

  • 00816063020875 ()


  • Dental milling system, CAD/CAM, chairside

iTero 5D Scanning Unit - 00816063020868

Scanning unit
Align Technology, Inc.
211783
In Commercial Distribution

  • 00816063020868 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element Scanning Unit - 00816063020851

Scanning unit
Align Technology, Inc.
211782
In Commercial Distribution

  • 00816063020851 ()


  • Dental milling system, CAD/CAM, chairside

iTero Mobile Computing Unit - 00816063020844

Scanner computer unit
Align Technology, Inc.
211386
In Commercial Distribution

  • 00816063020844 ()


  • Dental milling system, CAD/CAM, chairside

iTero Computing Unit - 00816063020837

Scanner computer unit
Align Technology, Inc.
211385
In Commercial Distribution

  • 00816063020837 ()


  • Dental milling system, CAD/CAM, chairside

iTero Wheel stand - 00816063020820

Scanner wheel stand
Align Technology, Inc.
211384
In Commercial Distribution

  • 00816063020820 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D Plus Ready US Mobile configuration - 00816063020813

Scanner, mobile configuration
Align Technology, Inc.
211899
In Commercial Distribution

  • 00816063020813 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D Plus Ready US Cart configuration - 00816063020806

Scanner, cart configuration
Align Technology, Inc.
211898
In Commercial Distribution

  • 00816063020806 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 2 Plus upgrade mobile configuration - 00816063020769

Scanner, mobile configuration
Align Technology, Inc.
211372
In Commercial Distribution

  • 00816063020769 ()


  • Dental milling system, CAD/CAM, chairside

iTero Element 5D Plus mobile configuration - 00816063020745

Scanner, mobile configuration
Align Technology, Inc.
211491
In Commercial Distribution

  • 00816063020745 ()


  • 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

PeriWatch Vigilance® Cues™ - B087PATT21011

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
21.01.xx
In Commercial Distribution

  • B087PATT21011 ()


  • 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

PeriWatch Vigilance® Cues™ - B087PATT202221

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
2022.2.xxx
In Commercial Distribution

  • B087PATT202221 ()


  • Obstetrical monitoring/analysis software

PeriWatch Vigilance® Cues™ - B087PATT02121

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
02.12.xx
In Commercial Distribution

  • B087PATT02121 ()


  • Obstetrical monitoring/analysis software

PeriWatch™ Vigilance™ Cues™ - B087PATT02101

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
02.10.xx
In Commercial Distribution

  • B087PATT02101 ()


  • Obstetrical monitoring/analysis software

PeriWatch™ Cues™ - B087PATT02081

PeriWatch™ 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
02.08.xx
In Commercial Distribution

  • B087PATT02081 ()


  • Obstetrical monitoring/analysis software
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