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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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Esteem®+ One-Piece Cut-To-Fit Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Transparent, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416700
In Commercial Distribution

  • 10768455111708 ()
  • 00768455111701 ()
  • 00768455188178 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 7/8" (22 Mm.)
CONVATEC, PURCHASING DEPARTMENT
650829
In Commercial Distribution

  • 10768455106629 ()
  • 00768455106622 ()
  • 00768455190232 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 3/4" (19 Mm.)
CONVATEC, PURCHASING DEPARTMENT
650828
In Commercial Distribution

  • 10768455106612 ()
  • 00768455106615 ()
  • 00768455190225 ()


  • One-piece urostomy bag, open-ended
PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Curetis GmbH
Acuitas AMR Gene Panel PCR Plate Kit
Not in Commercial Distribution

12001

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging.
Oehm und Rehbein GmbH
Amadeo M-DR mini with XenOR flat panel
Not in Commercial Distribution

  • 04250802902927 ()
  • 04250802902897 ()

  • Weight: 79 Kilogram
AM1622

  • Mobile basic diagnostic x-ray system, digital
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
No Description
Ziehm-Orthoscan, Inc.
1000-0020
In Commercial Distribution

  • B225100000200 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
Image-Intensified Fluoroscopic X-Ray, Mobile
Ziehm-Orthoscan, Inc.
1000-0017
In Commercial Distribution

  • B225100000170 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
Image-Intensified Fluoroscopic X-Ray System, Mobile
Ziehm-Orthoscan, Inc.
1000-0016
In Commercial Distribution

  • B225100000160 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
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