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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12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/PPX/BUP
UCP BIOSCIENCES, INC.
U-CUP-7124-RCN
In Commercial Distribution

  • 20817038020580 ()
  • 10817038020583 ()
  • 00817038020586 ()
U-CUP-7124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Cup TM Drug Test Screen 8 Panel Drug Test Cup BUP/BZO/COC/MET/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-384
In Commercial Distribution

  • 20817038021969 ()
  • 10817038021962 ()
  • 00817038021965 ()
U-CUP-384

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
UCP BIOSCIENCES, INC.
U-CUP-664-RCN
In Commercial Distribution

  • 20817038021617 ()
  • 10817038021610 ()
  • 00817038021613 ()
U-CUP-664-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Flat-Cup w/ADU (AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP+A3)
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-6125A3C
In Commercial Distribution

  • 00895330002844 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815021447 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 7 panel Cup - KCUR920096 AMP500/COC150/MDMA500/MET500/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920096
In Commercial Distribution

  • 00817815021232 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 7 panel Cup - KCUR920081 BAR300/BZO300/COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920081
In Commercial Distribution

  • 00817815021089 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815020778 ()
  • 00817815020785 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/OXY)
Instant Technologies, Inc.
USSCup-7BO CLIA
In Commercial Distribution

USSCup-7BO CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Preview Cup: AMP-500, BAR, BUP, BZO, COC-150, MDMA, MAMP/MET-500, MTD, MOP, OXY, PCP, PPX, TCA
WONDFO USA CO., LTD.
PRE-PDOA-9135A3
In Commercial Distribution

  • 10816862021780 ()
  • 00816862021783 ()
  • 00816862021790 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel E&I Oral Click Cube AMP50, BAR50, BUP5, BZO10, COC20, MDMA50, MET50, MTD30, OPI40, OXY20, THC40
Instant Technologies, Inc.
ABTOFCUBE1101A
In Commercial Distribution

  • 30817405023890 ()
  • 00817405023899 ()
  • 10817405023896 ()
ABTOFCUBE1101A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 PANEL CLIA WAIVED DIP CARD AMP1000,BAR300,BZO300,COC300,MDMA500,MET100,MOP300,MTD300,OXY100,PCP25,TCA1000,THC50
Instant Technologies, Inc.
ABTDOAW112402B
In Commercial Distribution

  • 30817405023586 ()
  • 00817405023585 ()
  • 10817405023582 ()
ABTDOAW112402B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 PANEL CLIA WAIVED DIP CARD AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50
Instant Technologies, Inc.
ABTDOAW112401A
In Commercial Distribution

  • 30817405023456 ()
  • 00817405023455 ()
  • 10817405023452 ()
ABTDOAW112401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 6 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6167-0-A
In Commercial Distribution

  • 00816036027108 ()
  • 00816036026606 ()
SCP-6167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 6 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/OPI/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2167-0-A
In Commercial Distribution

  • 00816036026545 ()
  • 00816036027047 ()
SCP-2167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 8 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR//THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STAII-3187-0
In Commercial Distribution

  • 00816036025449 ()
  • 00816036025432 ()
STATII-3187-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0
In Commercial Distribution

  • 00816036025104 ()
  • 00816036025265 ()
STATⅡ-41107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-21107-0
In Commercial Distribution

  • 00816036025098 ()
  • 00816036025258 ()
STATⅡ-21107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-6C1M5P
Not in Commercial Distribution

  • 00816565020274 ()
IMCA-6C1M5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. IDTC- 7 Panel Drug Screen (CR,SG,OX) for (COC/MET/MOP/MTD/BZO/OXY/BUP)
Cliawaived, Inc.
CLIA-IDTC-7BUP
In Commercial Distribution

  • 00816610020938 ()
CLIA-IDTC-7BUP

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

  • 00816610020860 ()
CLIA-IDTC-5-60527

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (40/50M
CONVATEC, PURCHASING DEPARTMENT
413523
In Commercial Distribution

  • 10768455130259 ()
  • 00768455130252 ()
  • 00768455187836 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (30/40M
CONVATEC, PURCHASING DEPARTMENT
413522
In Commercial Distribution

  • 10768455130242 ()
  • 00768455130245 ()
  • 00768455187829 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (20/30M
CONVATEC, PURCHASING DEPARTMENT
413521
In Commercial Distribution

  • 10768455130235 ()
  • 00768455130238 ()
  • 00768455187812 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 1 9/16" (40Mm)
CONVATEC, PURCHASING DEPARTMENT
416713
In Commercial Distribution

  • 10768455111838 ()
  • 00768455111831 ()
  • 00768455188291 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416710
In Commercial Distribution

  • 10768455111807 ()
  • 00768455111800 ()
  • 00768455188260 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Pre-Cut Closed-End Pouch, Modified Stomahesive, Filter, One-Sided Comfort Panel, 8" Opaque, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416707
In Commercial Distribution

  • 10768455111777 ()
  • 00768455111770 ()
  • 00768455188246 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ One-Piece Closed Pre-Cut, Modified Stomahesive® With Filter, 1 Comfort Panel, Standard 8", Transparent 1", 25Mm
CONVATEC, PURCHASING DEPARTMENT
416703
In Commercial Distribution

  • 10768455111739 ()
  • 00768455111732 ()
  • 00768455188208 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 19 - 50 mm
CONVATEC, PURCHASING DEPARTMENT
650422
Not in Commercial Distribution

  • 10768455106605 ()
  • 00768455106608 ()
  • 80768455106604 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 19 - 50 mm
CONVATEC, PURCHASING DEPARTMENT
650408
Not in Commercial Distribution

  • 10768455106599 ()
  • 00768455106592 ()
  • 80768455106598 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Little Ones® Drainable Pouch W/1 Sided Comfort Panel, 6" Transparent 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401928
In Commercial Distribution

  • 10768455104151 ()
  • 00768455104154 ()
  • 00768455183258 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Little Ones® Drainable Pouch W/1 Sided Comfort Panel, 6" Transparent 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401927
In Commercial Distribution

  • 10768455104144 ()
  • 00768455104147 ()
  • 00768455183241 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401555
In Commercial Distribution

  • 10768455103710 ()
  • 00768455103713 ()
  • 00768455182916 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401554
In Commercial Distribution

  • 10768455103703 ()
  • 00768455103706 ()
  • 00768455182909 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401553
In Commercial Distribution

  • 10768455103697 ()
  • 00768455103690 ()
  • 00768455182893 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401552
In Commercial Distribution

  • 10768455103680 ()
  • 00768455103683 ()
  • 00768455182886 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401551
In Commercial Distribution

  • 10768455103673 ()
  • 00768455103676 ()
  • 00768455182879 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch with Accuseal® Tap, Opaque Small, W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401550
In Commercial Distribution

  • 10768455103666 ()
  • 00768455103669 ()
  • 00768455182862 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Small, W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401549
In Commercial Distribution

  • 10768455103659 ()
  • 00768455103652 ()
  • 00768455182855 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Small, W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401548
In Commercial Distribution

  • 10768455103642 ()
  • 00768455103645 ()
  • 00768455182848 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Small, W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401547
In Commercial Distribution

  • 10768455103635 ()
  • 00768455103638 ()
  • 00768455182817 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401546
In Commercial Distribution

  • 10768455103628 ()
  • 00768455103621 ()
  • 00768455182800 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401545
In Commercial Distribution

  • 10768455103611 ()
  • 00768455103614 ()
  • 00768455182794 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401544
In Commercial Distribution

  • 10768455103604 ()
  • 00768455103607 ()
  • 00768455182787 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401543
In Commercial Distribution

  • 10768455103598 ()
  • 00768455103591 ()
  • 00768455182770 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Trans. Standard, W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401542
In Commercial Distribution

  • 10768455103581 ()
  • 00768455103584 ()
  • 00768455182763 ()


  • Multiple-piece urostomy bag, open-ended
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer
Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Curetis GmbH
Acuitas AMR Gene Panel Reagent Kit
Not in Commercial Distribution

12002

  • Nucleic acid amplification mastermix kit IVD
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