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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A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Cocaine, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601651
Not in Commercial Distribution

  • 10690286000268 ()
  • 00690286000261 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601640
Not in Commercial Distribution

  • 10690286000237 ()
  • 00690286000230 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Welch Allyn 767 Integrated Wall Diagnostic System including Coaxial Ophthalmoscope (#11720), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm)
WELCH ALLYN, INC.
901027
Not in Commercial Distribution

  • 00732094068498 ()
76792-MNOBP

  • Basic power supply, reusable
The EZ Lift PowerLift Beach Chair, Left Shoulder Panel Pad, 3 inch TLT (Tri Layer Technology) provide excellent pressure management and are used with STERIS General Surgical Tables.
STERIS CORPORATION
BF00010
In Commercial Distribution

  • 00724995203542 ()
BF00010

  • Operating table mattress, basic
The EZ Lift PowerLift Beach Chair, Right Shoulder Panel Pad, 3 inch TLT (Tri Layer Technology) provide excellent pressure management and are used with STERIS General Surgical Tables.
STERIS CORPORATION
BF00009
In Commercial Distribution

  • 00724995203535 ()
BF00009

  • Operating table mattress, basic
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
RANDOX LABORATORIES LIMITED
EV3550
In Commercial Distribution

  • 05055273202458 ()
EV3550

  • Multiple drugs of abuse IVD, calibrator
(Identify USA - Drug Test Cups) / 12 Panel CLIA Waived Cup - AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, MOR/OPI300, OXY100, PCP25, THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US12-BUP
In Commercial Distribution

  • 20850721007932 ()
  • 10850721007935 ()
  • 00850721007938 ()
ID-US12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI300/OXY/THC/BUP with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-DUD-7104-RCN
In Commercial Distribution

  • 20817038021921 ()
  • 10817038021924 ()
  • 00817038021927 ()
U-DUD-7104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/AMP/BUP with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-DUD-7104-RCN
In Commercial Distribution

  • 20817038021808 ()
  • 10817038021801 ()
  • 00817038021804 ()
U-DUD-7104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
TDOA-XC10A
In Commercial Distribution

  • 00817405021383 ()
  • 10817405021380 ()
TDOA-XC10A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12CLIA
Not in Commercial Distribution

USSCUPA-12CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (COC/MOP/AMP/MET/BAR/BZO/BUP/PCP/MDMA/MTD/OXY/TCA)
Instant Technologies, Inc.
USSCupA-12NTCLIA
In Commercial Distribution

USSCUPA12NTCLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-12BUP300CLIA
In Commercial Distribution

USSCUPA-12BUP30

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (AMP/BAR/BUP/BZO/COC/MET/OPI300/OXY/MTD/THC)
Instant Technologies, Inc.
I-DXP-2107-01
In Commercial Distribution

  • 00817405020355 ()
I-DXP-2107-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.13
In Commercial Distribution

  • 00850009343130 ()


  • Radiological PACS software
MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of medical data. MIMcloud also provides convenient methods for securely sharing medical data between users, with an aim to be a replacement for CD distribution. MIMcloud utilizes cloud computing to leverage near-limitless scalability, and universal access to create a network connecting institutions, clinicians, and patients.
MIM SOFTWARE INC.
2.12
Not in Commercial Distribution

  • 00850009343031 ()


  • Radiological PACS software
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176099 ()
LEH56IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176013 ()
LES56NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176006 ()
LES56NC02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175993 ()
LES56NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175504 ()
LEH11INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Dual Light with Single Flat Panel Monitor Mount, High Density Camera Ready, Single Cardanic with Tandem and Wall Control is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192426 ()
LGH42T

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176105 ()
LEH56INNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Hybrid High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176082 ()
LEH56IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175740 ()
LEH13INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175733 ()
LEH13IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175726 ()
LEH13IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175498 ()
LEH11IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175481 ()
LEH11IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173463 ()
LEH04INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173456 ()
LEH04IN02T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173449 ()
LEH04IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172749 ()
LEH02INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172732 ()
LEH02IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 13-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172725 ()
LEH02IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 20-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173425 ()
LEH04NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inchwith Single Flat Panel Monitor, 13-inch Drop Tube, No Camera is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173418 ()
LEH04NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inch with Single Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173357 ()
LES24NC01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inchwith Single Flat Panel Monitor, No Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173227 ()
LEH24INNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series High Definition Single Light 43-inch with Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173159 ()
LEH24IN02

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