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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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SeeMore - 00850921007035

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

Isansys - 05060488680304

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

Isansys - 05060488680267

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

Isansys - 05060488680250

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

Isansys - 05060488680205

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

Isansys - 05060488680182

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

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

ThinPrep Imaging System - 15420045512535

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504103

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD
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