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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STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-6167-0-A
In Commercial Distribution

  • 00816036025050 ()
  • 00816036025227 ()
STATⅡ-6167-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-0-A
In Commercial Distribution

  • 00816036025043 ()
  • 00816036025210 ()
STATⅡ-2167-3-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-3257-0-A
In Commercial Distribution

  • 00816036026538 ()
  • 00816036027030 ()
SCP-3257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, 25Pcs/Box AMP/COC/mAMP/OPI/THC + CR,OX,pH
MICRO DISTRIBUTING, L.C
SCP-1257-0-A
In Commercial Distribution

  • 00816036026514 ()
  • 00816036027016 ()
SCP-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
IDUN SOLUTIONS LLC
12511105000034
In Commercial Distribution

  • 90857275007813 ()


  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
MICROBIOLOGICS INC.
8250
In Commercial Distribution

  • 70845357043749 ()
8250

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8229
In Commercial Distribution

  • 70845357042728 ()
8229

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40
Instant Technologies, Inc.
ABTOFCUBE1102B
In Commercial Distribution

  • 30817405024040 ()
  • 00817405024049 ()
  • 10817405024046 ()
ABTOFCUBE1102B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel E&I Oral Click Cube AMP50, BAR50, BUP5, BZO10, COC20, MDMA50, MET50, MTD30, OPI40, OXY20,
Instant Technologies, Inc.
ABTOFCUBE1002B
In Commercial Distribution

  • 30817405023906 ()
  • 00817405023905 ()
  • 10817405023902 ()
ABTOFCUBE1002B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel CLIA Waived Click Cup AMP1000, BAR300, BUP10, BZO300, COC300, MET1000, MDMA500, MOP300, MTD300, OXY100, PCP25
Instant Technologies, Inc.
ABTDOAW111701A
In Commercial Distribution

  • 30817405023821 ()
  • 00817405023820 ()
  • 10817405023827 ()
ABTDOAW111701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BZO300, COC300, MET1000, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17702B
In Commercial Distribution

  • 30817405023326 ()
  • 00817405023325 ()
  • 10817405023322 ()
ABTDUAW17702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR, NI, OX, pH, S.G.)
Instant Technologies, Inc.
ABTDUAW15701A
In Commercial Distribution

  • 30817405023296 ()
  • 00817405023295 ()
  • 10817405023292 ()
ABTDUAW15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 PANEL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MOP300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW17701A
In Commercial Distribution

  • 30817405023265 ()
  • 00817405023264 ()
  • 10817405023261 ()
ABTDUAW17701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCup-10MMO300
Not in Commercial Distribution

USSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup W/ AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/(Cr/Ox/pH)
CHEMTRON BIOTECH INC
PCA-10NTSC-LC
In Commercial Distribution

  • 00812203030568 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-6-60669
In Commercial Distribution

  • 00816610020914 ()
CLIA-IDTC-6-60669

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5P
Not in Commercial Distribution

  • 00816565020236 ()
IMCA-5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5M
Not in Commercial Distribution

  • 00816565020229 ()
IMCA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5BO3
Not in Commercial Distribution

  • 00816565020212 ()
IMCA-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SUR-FIT Natura® Little Ones® Urostomy Pouch W/1 Sided Comfort Panel, Transparent 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401929
In Commercial Distribution

  • 10768455104168 ()
  • 00768455104161 ()
  • 00768455183265 ()


  • Multiple-piece urostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose®, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413518
In Commercial Distribution

  • 10768455130204 ()
  • 00768455130207 ()
  • 00768455187782 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (40/50Mm)
CONVATEC, PURCHASING DEPARTMENT
413517
In Commercial Distribution

  • 10768455130198 ()
  • 00768455130191 ()
  • 00768455187775 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413516
In Commercial Distribution

  • 10768455130181 ()
  • 00768455130184 ()
  • 00768455187768 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413515
In Commercial Distribution

  • 10768455130174 ()
  • 00768455130177 ()
  • 00768455187751 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413510
In Commercial Distribution

  • 10768455130068 ()
  • 00768455130061 ()
  • 00768455187737 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413509
In Commercial Distribution

  • 10768455130051 ()
  • 00768455130054 ()
  • 00768455187720 ()


  • One-piece intestinal ostomy bag, closed-ended
1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004001
In Commercial Distribution

  • 06977469280011 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004005
In Commercial Distribution

  • 06977469280004 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Right Small
In Commercial Distribution

  • 00810113680316 ()
EZA71RS

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Right Medium
In Commercial Distribution

  • 00810113680309 ()
EZA71RM

  • Ankle/foot orthosis
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