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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Schick AE Sensor Size 2 Ship Kit w/ 6ft Cable
SIRONA DENTAL, INC.
100007020
In Commercial Distribution

  • D7641000070201 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox Without Display
SIRONA DENTAL, INC.
100006465
In Commercial Distribution

  • D7641000064651 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox Display Upgrade Kit
SIRONA DENTAL, INC.
100006457
In Commercial Distribution

  • D7641000064571 ()


  • Dental digital imaging sensor, intraoral
Intraoral Sensor Wallbox With Display
SIRONA DENTAL, INC.
100006451
In Commercial Distribution

  • D7641000064510 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S0 Front Can Attach
SIRONA DENTAL, INC.
100006074
In Commercial Distribution

  • D7641000060740 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S1 Front Can Attach
SIRONA DENTAL, INC.
100006040
In Commercial Distribution

  • D7641000060400 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S2 Front Can Attach
SIRONA DENTAL, INC.
100006036
In Commercial Distribution

  • D7641000060360 ()


  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344701 ()
16000004525

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344695 ()
16000004524

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340727 ()
16000004374

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340697 ()
16000004373

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340284 ()
16000004138

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340277 ()
16000004137

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340260 ()
16000004136

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340253 ()
16000004135

  • Dental digital imaging sensor, intraoral
Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44
STANDARD TEXTILE CO., INC.
95301682
In Commercial Distribution

  • 00634916000016 ()
  • 10634916000013 ()
95301682

  • Patient surgical drape, reusable
BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)
MERCEDES MEDICAL, LLC
TNR CDOA7125A3
In Commercial Distribution

  • 00850011007112 ()
  • 10850011007119 ()
  • 20850011007116 ()
TNR CDOA7125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995172800 ()
LES02INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light 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

  • 00724995172794 ()
LES02IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Dual Light with Single Flat Panel Monitor, 13-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

  • 00724995172787 ()
LES02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAir E-Series High Definition Dual Light, Single Flat Panel Monitor, Auxiliary 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

  • 00724995172145 ()
LEH03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single High Definition Light 35-inch with 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

  • 00724995168414 ()
LEH04

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR E-Series High Definition 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

  • 00724995168391 ()
LEH24

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The HarmonyAIR E-Series Spindle Hybrid Single Light Dual Flat Panel Monitor High Definition is a ceiling supported lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995170981 ()
LEH000018

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR E-Series Hybrid High Definition 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

  • 00724995168667 ()
LEH56

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith 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

  • 00724995173272 ()
LES24IN02

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

  • 00724995175801 ()
LES13INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual 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

  • 00724995175795 ()
LES13IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-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

  • 00724995175788 ()
LES13IN01

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

  • 00724995175566 ()
LES11INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual 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

  • 00724995175559 ()
LES11IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-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

  • 00724995175542 ()
LES11IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605200
In Commercial Distribution

  • 00690286000483 ()
  • 10690286000480 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Amphetamine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605104
In Commercial Distribution

  • 00690286000452 ()
  • 10690286000459 ()


  • 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 Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601599
In Commercial Distribution

  • 00690286000346 ()
  • 10690286000343 ()


  • 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 Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601638
Not in Commercial Distribution

  • 10690286000213 ()
  • 00690286000216 ()


  • 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 Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601594
Not in Commercial Distribution

  • 10690286000152 ()
  • 00690286000155 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731958 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731941 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731934 ()


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