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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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Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022765
In Commercial Distribution

  • 10768455101556 ()
  • 00768455101559 ()
  • 00768455179190 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022762
In Commercial Distribution

  • 10768455101525 ()
  • 00768455101528 ()
  • 00768455179169 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022758
In Commercial Distribution

  • 10768455101488 ()
  • 00768455101481 ()
  • 00768455179121 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 2" (50 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022755
In Commercial Distribution

  • 10768455101457 ()
  • 00768455101450 ()
  • 00768455179091 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Pre-Cut Drainable Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 10" Opaque, 1" (25 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022751
In Commercial Distribution

  • 10768455101419 ()
  • 00768455101412 ()
  • 00768455179053 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12", Transparent 13/16-2 3/4", 20-70Mm
CONVATEC, PURCHASING DEPARTMENT
421848
In Commercial Distribution

  • 10768455153166 ()
  • 00768455153169 ()
  • 00768455172580 ()


  • One-piece intestinal ostomy bag, closed-ended
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Inc.
RMD-WEB-I
Not in Commercial Distribution

  • B037RESMDWEB0 ()


  • Radiological PACS software
ResolutionMD® Mobile is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant medical images as well as reports on the mobile device.
ResolutionMD Inc.
RMD-MOB-I
Not in Commercial Distribution

  • B037RESMDMOB0 ()


  • Radiological PACS software
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
Image-Intensified Fluoroscopic X-Ray System, Mobile
Ziehm-Orthoscan, Inc.
1000-0015
In Commercial Distribution

  • B225100000150 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
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
A qualitative one-step immunochromatographic test panel for the detection of Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605211
In Commercial Distribution

  • 10690286000695 ()
  • 00690286000698 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOBCLIA
Not in Commercial Distribution

  • 00858998006180 ()
USSCupA-7MOBCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214135 ()
LES31NC02T

  • Medical monitor/light mount
The E-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995214128 ()
LES31NC01T

  • Medical monitor/light mount
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