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 Light with Camera-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167110 ()
LGH08NT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Adjustable Camera, No Control, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167080 ()
LGH08N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167028 ()
LG41NT

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

  • 00724995166984 ()
LG37N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual Fixed with Single Flat Panel Monitor, No Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166885 ()
LG11NFT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Dual Fixed with Single Flat Panel Monitor, No Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166861 ()
LG11NF

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Dual Adjustable No Camera with Single Flat Panel Monitor is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166854 ()
LG11N

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

  • 00724995166823 ()
LG07NFT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Adjustable No Camera-Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166816 ()
LG07NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The G5 Single Fixed-with Single Flat Panel Monitor, No Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166809 ()
LG07NF

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

  • 00724995166670 ()
LGH00034

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

  • 00724995166663 ()
LGH00033

  • Medical monitor/light mount
The Dual Air M7/M5 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

  • 00724995166021 ()
LM08NT

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The Dual M5 without Control 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

  • 00724995165727 ()
LM02NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Air Single M7 High Density 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

  • 00724995165710 ()
LMH09N

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
Six Panel Clear Scan Drug Test Cup with Adulterants Drug Combo AMP/BZO/COC/MET/OPI/THC with Adulterants
MERGERS MARKETING, INC.
CSC-264AD
In Commercial Distribution

  • 00851000007328 ()
  • 00851000007335 ()
  • 10851000007332 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 8 Panel, CLIA Waived, AMP, BUP, BZO, COC, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-285T
In Commercial Distribution

  • 00850798007626 ()
  • 00850798007619 ()
  • 00850798007602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR E-Series Spindle Single Light 35.5-inch Dual Flat Panel Monitor High Density is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170974 ()
LEH000017

  • Medical monitor/light mount
The Dual Spindle Single Flat Panel Monitor Light Head 11008900 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170417 ()
LG00028

  • Medical monitor/light mount
u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
UCP BIOSCIENCES, INC.
UDO-6123
In Commercial Distribution

  • 20817038021907 ()
  • 10817038021900 ()
  • 00817038021903 ()
UDO-6123

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Cup Drug Test Screen 10 Panel Drug Test Cup (BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC)
UCP BIOSCIENCES, INC.
U-CUP-7104
In Commercial Distribution

  • 20817038021860 ()
  • 10817038021863 ()
  • 00817038021866 ()
U-CUP-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-8134-RCN
In Commercial Distribution

  • 20817038020641 ()
  • 10817038020644 ()
  • 00817038020647 ()
U-CUP-8134-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 12 Panel CLIA Dip Card AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-6125
In Commercial Distribution

  • 00895330002639 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • 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
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 12 Panel Dip Card CLIA AMP1000/BAR300/BUP10/BZO300/COC300/THC50/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-9124
In Commercial Distribution

  • 00895330002615 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6124
In Commercial Distribution

  • 00895330002561 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MTD300/MOP2000/OXY100/PCP25/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3124
In Commercial Distribution

  • 00895330002547 ()


  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
12 Panel One Step DOA Cup (12.5) - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 PCP25
BTNX Inc
D12.5-1VF
In Commercial Distribution

  • 00722066007549 ()
  • 10722066007546 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 14 Panel THC/COC/PCP/mAMP/AMP/MDMA/TCA/BAR/BZO/MTD/OXY/PPX/BUP/OPI
RITE AID CORPORATION
8024512
In Commercial Distribution

  • 00011822001670 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Propoxyphene IVD, reagent
  • Nortriptyline IVD, reagent
Sterile Labels, 10 labels per panel, 2 panels per pouch, 100 packages per box, Custom Medical Labels for CAME017
KEY SURGICAL, INC.
SL212
In Commercial Distribution

  • 50849771043176 ()
  • 10849771043178 ()
  • 00849771043171 ()
SL212

  • Procedural medication labelling set
mLife Verify 11 Panel Oral Fluid Drug Test FYL AMP COC MET OPI THC BAR BZO MDMA OXY PCP
Mlife Diagnostics, LLC
MV002.11.0001EI
In Commercial Distribution

  • G474MV002110001EI0 ()


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