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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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CYSTO GRID MARKER STAINLESS STEEL
ELMED INCORPORATED
83-31000-CC
In Commercial Distribution

  • 00198506058103 ()
83-31000-CC

  • Robotic surgical system application software
GUYON Catheter Guide GUYON cm, 15-1/2"
ELMED INCORPORATED
ST310703939
In Commercial Distribution

  • 00198506001659 ()
ST310703939

  • Robotic surgical system application software
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.6
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.4
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.5
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
N/A
Carl Zeiss Vision GmbH
000000-1011-377
Not in Commercial Distribution

  • 04250668606748 ()
000000-1011-377

  • Multidisciplinary medical image management software
N/A
Carl Zeiss Vision GmbH
000000-2360-422
In Commercial Distribution

  • 04250668606632 ()
000000-2360-422

  • Corneal topography system application software
N/A
Carl Zeiss Vision GmbH
000000-2265-586
In Commercial Distribution

  • 04250668606618 ()
000000-2265-586

  • Multidisciplinary medical image management software
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
SafeID 2.3
VISION RT LIMITED
SafeID 2.3
In Commercial Distribution

  • 05056190500801 ()


  • Patient-administration information system application software
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