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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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Epocal Inc
HH-0003-XU-00
Not in Commercial Distribution

  • 00809708046514 ()


  • Metabolic profile clinical chemistry analyser IVD
Custom Abutment Ti, RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717764 ()
040.689

  • Dental implant suprastructure, permanent, preformed
Data entry & local display point tablet computer, 10.5 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway SM-X200 – 10.5 - WiFi
In Commercial Distribution

  • 05060488680304 ()
Gateway SM-X200 – 10.5 - WiFi

  • Physiological measuring device wireless data capture/transfer unit
Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T515 - 10.1 - GSM
In Commercial Distribution

  • 05060488680267 ()
Gateway T515 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit
Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T510 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680250 ()
Gateway T510 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit
Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - GSM
In Commercial Distribution

  • 05060488680205 ()
Patient Gateway T580 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit
Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680182 ()
Gateway T580 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit
Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7450
In Commercial Distribution

  • 00851725007153 ()
RNS-6803-7450

  • Centralized patient monitor
Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • Centralized patient monitor
USB ultrasound probe, general purpose/abdominal, with tablet computer
INTERSON CORP
ViewBladder 10
In Commercial Distribution

  • 00850921007035 ()
99-9008

  • Extracorporeal ultrasound imaging transducer, hand-held
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