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 M7 Single High Density Package with Hub Spacer, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191788 ()
LMH29T

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

  • 00724995191702 ()
LM29T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The M7 Single Package with Single High Density Flat Panel Monitor Mount, No Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191689 ()
LM09T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5 High Density Single Package with Hub Spacer, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191535 ()
LMH24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D12.2-1P29-25
In Commercial Distribution

  • 00722066003688 ()
  • 00722066004074 ()
D12.2-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Dual Spindle Light Head with Video 1750mm Single Flat Panel Monitor 1600mm G-Series 11008906 is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
In Commercial Distribution

  • 00724995170479 ()
LK00015

  • Medical monitor/light mount
The HarmonyAIR E-Series Single Light 35-inch, Single 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

  • 00724995168421 ()
LES04

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series Single Light 43-inch, Single 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

  • 00724995168407 ()
LES24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Single Light, Camera Hybrid, Single Flat Panel Monitor, Single Cardanic and Spring Arm is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167219 ()
LGH25N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Single Light, with Camera with ConnectPoint Express, Single Flat Panel Monitor and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167172 ()
LGH14NCT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Single High Density M5, No Control with Single Flat Panel Monitor Spring Arm, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166595 ()
LMH24NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR E-Series Dual Flat Panel Monitor ARM, 67-inch ARM 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

  • 00724995168674 ()
LES57

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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
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