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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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Adult/Pediatric flow sensor. Pack of 10.
TREYMED INC
Adult/Pediatric
In Commercial Distribution

  • B23133121 ()
  • B23133120 ()
3312

  • Breathing circuit gas-sampling/monitoring set
ScanX 12 SE is a device that scans photostimulable phosphor plates that have been exposed in the place of x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It is used as a podiatry unit.
AIR TECHNIQUES, INC.
F3805
In Commercial Distribution

  • D678F38050 ()
  • D678F38051 ()
  • D678F38001 ()

  • Depth: 14 Inch
  • Width: 14 Inch
  • Height: 28 Inch


  • Radiography digital imaging scanner
300, 400, 500 Series Surgical Instrument Kit
Implant Logistics, Inc.
KIT-SUIN-00
In Commercial Distribution

  • D762KITSUIN000 ()


  • Dental implant system
  • Surgical screwdriver, reusable
  • Dental torque wrench adaptor
The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
Thermogenesis Corp.
SGI-0777
In Commercial Distribution

  • B039SGI07770 ()


  • Blood centrifugation system application software
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.
DE GÖTZEN SRL
ACTEON IMAGING SUITE
In Commercial Distribution

  • D804W09000460 ()
W0900046

  • Panoramic/tomographic dental x-ray system application software
The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders.
Heidelberg Medical Inc
Heidelberg pH Capsule System
In Commercial Distribution

  • B989HPHDS180 ()
HPHDS18

  • Gastrointestinal telemetric monitoring system
Acteon Imaging Suite software program is an application software for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. It is distributed on DVD
DE GÖTZEN SRL
ACTEON IMAGING SUITE (DVD):
In Commercial Distribution

  • D8049902630 ()
990263

  • Panoramic/tomographic dental x-ray system application software
The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
D1100
In Commercial Distribution

  • D678D11000 ()
  • D678D1000F1 ()
  • D678D11001 ()

  • Height: 12 Inch
  • Depth: 10.375 Inch
  • Width: 10 Inch
  • Weight: 21.5 Pound


  • Radiography digital imaging scanner
ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution

  • D678F37050 ()
  • D678F37001 ()
  • D678F3700U1 ()
  • D678F37051 ()
  • D678F3700C1 ()
  • D678F3750C1 ()
  • D678F37501 ()

  • Height: 24.5 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 51 Pound


  • Radiography digital imaging scanner
ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3605
In Commercial Distribution

  • D678F36050 ()
  • D678F36001 ()
  • D678F3600U1 ()
  • D678F36051 ()
  • D678F3600C1 ()

  • Height: 16 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 44 Pound
F3600

  • Radiography digital imaging scanner
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