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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 Class Implantable

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Bolt Navigation - B981BN00201103

Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN0010101

Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution

  • B981BN0010101 ()
BN001-01-01

  • Surgical planning/navigation-enhancement system

Augmented Reality Application - G67910

No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system

Criticare - B438560DNUS0

Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNVP30

Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNP30

Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNVP30

Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical

VisAR - B109VISAR2880

VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.88
In Commercial Distribution

  • B109VISAR2880 ()


  • Surgical planning/navigation-enhancement system

VisAR - B109VISAR2730

VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.73
In Commercial Distribution

  • B109VISAR2730 ()


  • Surgical planning/navigation-enhancement system
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