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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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ManoScan - 04260167482262

Assy, Retail Box of 20, ManoShield SD
Given Imaging, Inc.
MSS-4360
In Commercial Distribution

  • 04260167482262 ()
  • 10884521742727 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482248

Assy, Retail Box of 10, ManoShield AR
Given Imaging, Inc.
MSS-3599
In Commercial Distribution

  • 04260167482248 ()
  • 10884521742734 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482200

Assy, Retail Box of 20, ManoShield EG
Given Imaging, Inc.
MSS-2155
In Commercial Distribution

  • 04260167482200 ()
  • 10884521742741 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167480961

ESO Catheter, SD Regular
Given Imaging, Inc.
3887
In Commercial Distribution

  • 04260167480961 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167480954

AR 3D Probe
Given Imaging, Inc.
3885
In Commercial Distribution

  • 04260167480954 ()


  • Manometric gastrointestinal motility analysis system

FCRView - 04547410316926

FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
FUJIFILM CORPORATION
CR-VW674
In Commercial Distribution

  • 04547410316926 ()


  • Diagnostic x-ray digital imaging system workstation

Chroma 7 Lead Patient Cable - 00856298006312

7 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100608
In Commercial Distribution

  • 00856298006312 ()


  • Electrocardiographic ambulatory recorder

Chroma 5 Lead Patient Cable - 00856298006220

5 lead ECG patient cable to be used with the Chroma device.
SCOTTCARE CORPORATION, THE
100605
In Commercial Distribution

  • 00856298006220 ()


  • Electrocardiographic ambulatory recorder

Chroma2 - 00856298006015

No Description
SCOTTCARE CORPORATION, THE
RZ153C2
In Commercial Distribution

  • 00856298006015 ()
101942

  • Electrocardiographic ambulatory recorder

Chroma - 00856298006008

The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) continuous recording of ambulatory electrocardiograph (AECG) data on a single AAA battery. It has the ability to detect and record pacemaker pulses according to the appropriate criteria for Association for the Advancement of Medical Instrumentation (AAMI) pacer detection.
SCOTTCARE CORPORATION, THE
RZ153C
In Commercial Distribution

  • 00856298006008 ()
101273

  • Electrocardiographic ambulatory recorder
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