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 G5 Single No Camera Hybrid Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166922 ()
LG22N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Single Flat Panel Monitor, Light Head with Video-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166717 ()
LGH00036

  • Medical monitor/light mount
The Single M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166502 ()
LM06N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Air Single M7 with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166052 ()
LM09NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Air Dual M7/M5 with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166014 ()
LM08N

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series Spindle Single Light Single Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170851 ()
LEH000003

  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Dual Light Single Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170837 ()
LEH000001

  • Medical monitor/light mount
The Single M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165642 ()
LM04N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The Dual M5 without Control with Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165611 ()
LM02N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The 1 Box Touch Panel Control Unit Power Supply M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165543 ()
LM0016

  • Medical monitor/light mount
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
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
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
Siemens TXT couchtop with grid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™ reloadable frame
MEDTEC, INC.
MTIL3015
Not in Commercial Distribution

  • 00841439104620 ()
MTIL3015

  • Indexed-immobilization patient positioning system
Siemens ZXT Couchtop with solid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™ reloadable frame
MEDTEC, INC.
MTIL301004
Not in Commercial Distribution

  • 00841439104583 ()
MTIL301004

  • Indexed-immobilization patient positioning system
Siemens ZXT couchtop with grid panel, Prodigy™ Lok-Bar™, Type-S™ extension, and Type-S™ reloadable frame
MEDTEC, INC.
MTIL3010
Not in Commercial Distribution

  • 00841439104545 ()
MTIL3010

  • Indexed-immobilization patient positioning system
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-8124-RCN
In Commercial Distribution

  • 20850721007253 ()
  • 10850721007256 ()
  • 00850721007259 ()
U-CUP-8124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Screening Test Cup THC/COC/OPI300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
UCP12-BUP-AZ5
In Commercial Distribution

  • 20850721007215 ()
  • 10850721007218 ()
  • 00850721007211 ()
UCP12-BUP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-3124-RCN
In Commercial Distribution

  • 20850721007123 ()
  • 10850721007126 ()
  • 00850721007129 ()
U-CUP-3124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-3124-RCN
In Commercial Distribution

  • 20817038020658 ()
  • 10817038020651 ()
  • 00817038020654 ()
U-CUP-3124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-10124-RCN
In Commercial Distribution

  • 20817038020603 ()
  • 10817038020606 ()
  • 00817038020609 ()
U-CUP-10124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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
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
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
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