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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The HarmonyAIR E-Series Hybrid Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168650 ()
LES56

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
ELMED COLPOSCOPE EX955 W/ VIDEO-DIGITAL PACKAGE, INCLUDES: BEAM SPLITTER, VIDEO ADAPTER, DIGITAL ADAPTER OR BOTH, VIDEO CAMERA 7 19” FLAT PANEL LCD MONITER
ELMED INCORPORATED
ST9955P
In Commercial Distribution

  • 00198506072710 ()
ST9955P

  • Colposcope
Identify® Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ25
In Commercial Distribution

  • 20850721007697 ()
  • 10850721007690 ()
  • 00850721007693 ()
ID-CP12-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ10
In Commercial Distribution

  • 20850721007604 ()
  • 10850721007607 ()
  • 00850721007600 ()
ID-CP12-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 12 panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP-AZ5
In Commercial Distribution

  • 20850721007536 ()
  • 10850721007539 ()
  • 00850721007532 ()
ID-CP12-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cards 12 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/BUP/AMP/BAR/BZO/MET/MTD/PCP
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-DIP
In Commercial Distribution

  • 20850721007659 ()
  • 10850721007652 ()
  • 00850721007655 ()
ID-CP12-DIP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038022263 ()
  • 10817038022266 ()
  • 00817038022269 ()
U-DUD-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cards 12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-DOA-3124
In Commercial Distribution

  • 20817038021471 ()
  • 10817038021474 ()
  • 00817038021477 ()
U-DOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR/Ni/pH) 10 Panel Drug Screen (AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
USSCupA-10NT
In Commercial Distribution

  • 10817405021366 ()
  • 00817405021369 ()
USSCupA-10NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 7 Panel Saliva Test Cup E/I Screening (D7.27-2FC1E)- AMP50, COC20, MET50, OPI40, OXY20, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D7.27-2FC1E
In Commercial Distribution

  • 00722066006818 ()
  • 10722066006815 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-11OP
Not in Commercial Distribution

  • 00816565020311 ()
IMCA-11OP

  • 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 Technologies, Inc.
USSCupA-7MOBCLIA
In Commercial Distribution

USSCupA-7MOBCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. IDTC- 5 Panel Cup with Adulterants (CR, SG, OX) (COC 300,MET 1000,OPI 300, OXY 100, THC 50)-(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-5-60527a
In Commercial Distribution

  • 00816610020822 ()
CLIA-IDTC-5-60527a

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. IDTC- 11 Panel Cup with no THC (COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, TCA)-(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-11-NTHC
In Commercial Distribution

  • 00816610020785 ()
CLIA-IDTC-11-NTHC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP SCP-32107-0-A,10 Panel Test Cup w/Adulterants, AMP/BAR/BUP/BZO/COC/mAMP/MTD/MOR/OXY/THC + CR,OX,pH, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-32107-0-A
In Commercial Distribution

  • 00816036027115 ()
  • 00816036026613 ()
SCP-32107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-83127-0-A
In Commercial Distribution

  • 00816036025142 ()
  • 00816036025302 ()
STATII-83127-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-71127-0-A
In Commercial Distribution

  • 00816036025135 ()
  • 00816036025296 ()
STATⅡ-71127-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per box
MICRO DISTRIBUTING, L.C
STATII-71127-0-OTC
In Commercial Distribution

  • 00816036025418 ()
STATII-71127-0-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 2 1/2" (64Mm.)
CONVATEC, PURCHASING DEPARTMENT
125344
In Commercial Distribution

  • 10768455102058 ()
  • 00768455102051 ()
  • 00768455180585 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1 3/4" (45Mm.)
CONVATEC, PURCHASING DEPARTMENT
125342
In Commercial Distribution

  • 10768455102034 ()
  • 00768455102037 ()
  • 00768455180561 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1 1/2" (38Mm.)
CONVATEC, PURCHASING DEPARTMENT
125341
In Commercial Distribution

  • 10768455102027 ()
  • 00768455102020 ()
  • 00768455180554 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1 1/4" (32Mm.)
CONVATEC, PURCHASING DEPARTMENT
125340
In Commercial Distribution

  • 10768455102010 ()
  • 00768455102013 ()
  • 00768455180547 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 2 1/2" (64Mm.)
CONVATEC, PURCHASING DEPARTMENT
125337
In Commercial Distribution

  • 10768455101983 ()
  • 00768455101986 ()
  • 00768455180516 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch with Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 1 3/4" (45Mm.)
CONVATEC, PURCHASING DEPARTMENT
125335
In Commercial Distribution

  • 10768455101969 ()
  • 00768455101962 ()
  • 00768455180493 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 1 1/2" (38Mm.)
CONVATEC, PURCHASING DEPARTMENT
125334
In Commercial Distribution

  • 10768455101952 ()
  • 00768455101955 ()
  • 00768455180486 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 1 1/4" (32Mm.)
CONVATEC, PURCHASING DEPARTMENT
125333
In Commercial Distribution

  • 10768455101945 ()
  • 00768455101948 ()
  • 00768455180479 ()


  • One-piece intestinal ostomy bag, open-ended
Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 3/4" (19 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022764
In Commercial Distribution

  • 10768455101549 ()
  • 00768455101542 ()
  • 00768455179183 ()


  • 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, 3/4" (19 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022757
In Commercial Distribution

  • 10768455101471 ()
  • 00768455101474 ()
  • 00768455179114 ()


  • 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, 3/4" (19 Mm.)
CONVATEC, PURCHASING DEPARTMENT
022750
In Commercial Distribution

  • 10768455101402 ()
  • 00768455101405 ()
  • 00768455179046 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Cut-To-Fit Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416701
In Commercial Distribution

  • 10768455111715 ()
  • 00768455111718 ()
  • 00768455188185 ()


  • One-piece intestinal ostomy bag, closed-ended
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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