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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WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & VERTICAL REMOTE MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184BC-C
In Commercial Distribution

  • D0692184BCC0 ()


  • Dental delivery system
OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector) Drape, Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31047
In Commercial Distribution

  • 10618125190826 ()
  • 00618125190812 ()
8849416

  • Medical equipment/instrument drape, single-use
Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3104
In Commercial Distribution

  • 00895330002769 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-8104A3
In Commercial Distribution

  • 00895330002745 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-8104
In Commercial Distribution

  • 00895330002677 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 10 Panel Dip Card - BAR300/BUP10/BZO300/COC300/mAMP1000/MTD300/MOP2000/OXY100/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002820 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ25
In Commercial Distribution

  • 20850721007673 ()
  • 10850721007676 ()
  • 00850721007679 ()
ID-CP5-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ5
In Commercial Distribution

  • 20850721007505 ()
  • 10850721007508 ()
  • 00850721007501 ()
ID-CP5-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-6104-RCN
In Commercial Distribution

  • 20850721007055 ()
  • 10850721007058 ()
  • 00850721007051 ()
U-CUP-6104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ10
In Commercial Distribution

  • 20850721007611 ()
  • 10850721007614 ()
  • 00850721007617 ()
ID-CP5-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Sterile Labels - Custom TNHO0004, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL214
In Commercial Distribution

  • 20849771052924 ()
  • 10849771052927 ()
  • 00849771052920 ()
SL214

  • Procedural medication labelling set
Sterile Labels - Custom FLHU009, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL213
In Commercial Distribution

  • 20849771052917 ()
  • 10849771052910 ()
  • 00849771052913 ()
SL213

  • Procedural medication labelling set
Sterile Labels - Custom MATR002, 10 labels per panel, 4 panels per pouch, 100 packages per box.
KEY SURGICAL, INC.
SL402
In Commercial Distribution

  • 20849771040013 ()
  • 10849771040016 ()
  • 00849771040019 ()
SL402

  • Procedural medication labelling set
Sterile Labels - Custom INBL005, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL215
In Commercial Distribution

  • 20849771040006 ()
  • 10849771040009 ()
  • 00849771040002 ()
SL215

  • Procedural medication labelling set
Sterile Labels - Sterile Labels -10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 50849771050723 ()
  • 10849771050725 ()
  • 00849771050728 ()
  • 00849771032922 ()
SL203

  • Procedural medication labelling set
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card TM Drug Test Screen 7 panel Test Card COC/AMP/MET/THC/OPI/BZO/OXY
UCP BIOSCIENCES, INC.
U-DOA-374L
In Commercial Distribution

  • 10817038022013 ()
  • 00817038022016 ()
  • 20817038022010 ()
U-DOA-374L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET
UCP BIOSCIENCES, INC.
U-CUP-564
In Commercial Distribution

  • 20817038021945 ()
  • 10817038021948 ()
  • 00817038021941 ()
U-CUP-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-6124L
In Commercial Distribution

  • 20817038021358 ()
  • 10817038021351 ()
  • 00817038021354 ()
U-DOA-6124L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-254
In Commercial Distribution

  • 20817038021280 ()
  • 10817038021283 ()
  • 00817038021286 ()
U-DUD-254

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

  • 00816036025012 ()
  • 00816036025180 ()
STATⅡ-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATII-4267-0
In Commercial Distribution

  • 00816036025388 ()
  • 00816036025395 ()
STATII-4267-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 5 panel Dip - KCUR920102 AMP500/COC150/MET500/OPI2000/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920102
In Commercial Distribution

  • 00817815021263 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Dip - KCUR920085 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920085
In Commercial Distribution

  • 00817815021201 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 5 panel Cup - KCUR920079 COC300/MET1000/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920079
In Commercial Distribution

  • 00817815021027 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 Panel Dip - KCUR920075 AMP1000/BAR300/BZO300/COC300/MET 1000/MTD300/OPI2000/PCP25/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920075
In Commercial Distribution

  • 00817815020969 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker + 3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-5125A3
In Commercial Distribution

  • 20816490020824 ()
  • 10816490020827 ()
  • 00816490020820 ()
HCDOAV-5125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup With Clicker;+3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-6124A3
In Commercial Distribution

  • 20816490020800 ()
  • 10816490020803 ()
  • 00816490020806 ()
HCDOAV-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;+3 Adulterant Test Strips OXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAV-6125A3
In Commercial Distribution

  • 20816490020794 ()
  • 10816490020797 ()
  • 00816490020790 ()
HCDOAV-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)
MICROBIOLOGICS INC.
8254
In Commercial Distribution

  • 70845357044098 ()
8254

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
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