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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No Description
ECHOLIGHT SPA
EchoS
In Commercial Distribution



  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
OsteoStudio
In Commercial Distribution

  • 08052461860091 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
OsteoS
In Commercial Distribution

  • 08052461860060 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoStudio
In Commercial Distribution

  • 08052461860046 ()


  • Bioelectrical body composition analyser
  • Bone absorptiometric ultrasound system
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
R006208
In Commercial Distribution

  • 09353278000465 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
P006208
In Commercial Distribution

  • 09353278000267 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand
ECHONOUS, INC.
P006105
In Commercial Distribution

  • 09353278000250 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiographic lead set, reusable
  • Electronic acoustic stethoscope
Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1000/mAMP1000/BAR300/BZO300/COC300/MTD300/MDMA500/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6104
In Commercial Distribution

  • 00856464008386 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methadone IVD, reagent
NexScreen Drug Dip Card 9 Panel (6AM) 6AM10/AMP500/COC150/MDMA500/MET500/ MOR300/OXY100/PCP25/THC50
NEXSCREEN, LLC
NCard-09-6AM
In Commercial Distribution

  • 00858984006293 ()
NCard-09-6AM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HarmonyAIR A-Series Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995203245 ()
LAS14

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR G-Series Spring, Single Flat Panel Monitor is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension System
In Commercial Distribution

  • 00724995207397 ()
LG000001V

  • Medical monitor/light mount
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002076 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002052 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
MDC-694
In Commercial Distribution

  • 00860113002069 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002045 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002038 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
Medical Disposables Corp
M-DOA-694
In Commercial Distribution

  • 00860113002021 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Touch Panel Control Unit without Power Supply is used with the M Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995190675 ()
11017151

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

  • 00724995171148 ()
LES000018

  • Medical monitor/light mount
The E-Series Spindle Single Light 35.5-inch Dual Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171131 ()
LES000017

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

  • 00724995171025 ()
LES000004

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

  • 00724995171018 ()
LES000003

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

  • 00724995170998 ()
LES000001

  • Medical monitor/light mount
The HarmonyAIR E-Series 59-inch Auxiliary Arm Single Flat Panel Monitor is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170677 ()
LES0071

  • Medical monitor/light mount
The HarmonyAIR E-Series Single Flat Panel Monitor Yoke with Handle is a ceiling supported suspension system.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995170561 ()
LES0002

  • Medical monitor/light mount
One Step 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
BTNX Inc
D9.11-1V
In Commercial Distribution

  • 00722066004678 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Drug Test Panel - 25/kit(10.22) - COC300 AMP1000 MET1000 THC50 MTD300 MOP300 OXY100 BAR300 BZO300 BUP10
BTNX Inc
D10.22-1P29-25
In Commercial Distribution

  • 00722066004593 ()
  • 00722066004609 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Dual Flat Panel Light Head Spindle-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166656 ()
10088696

  • Medical monitor/light mount
The M-Series Flat Panel Monitor Spring Arm Assembly is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165499 ()
LM0021

  • Medical monitor/light mount
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC|AMP|MET|THC|OPI|PCP
MERGERS MARKETING, INC.
PS-DOA-164
In Commercial Distribution

  • 20851000007155 ()
  • 10851000007158 ()
  • 00851000007151 ()


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