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-Series Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, Non-Camera, Tandem is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995201098 ()
LAS14NC01T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, No Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200909 ()
LAH14INND

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200893 ()
LAH14IN02

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series High Definition Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200886 ()
LAH14IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, No Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200848 ()
LAS31NCND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 20-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200831 ()
LAS31NC02

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
A-Series Dual Flat Panel Monitor Arm, 51-inch Arm, 13-inch Drop Tube, Non-Camera is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200824 ()
LAS31NC01

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA2135
In Commercial Distribution

  • 00850011007105 ()
  • 10850011007102 ()
  • 20850011007109 ()
TNR CDOA2135

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA
MERCEDES MEDICAL, LLC
TNR MMC12MOP
In Commercial Distribution

  • 00850011007099 ()
  • 10850011007096 ()
  • 20850011007093 ()
TNR MMC12MOP

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone 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 T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent
T2 BIOSYSTEMS, INC.
90-11400
In Commercial Distribution

  • M70890114000 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-G
In Commercial Distribution

  • D0692502MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-C
In Commercial Distribution

  • D0692502MCCC0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC
In Commercial Distribution

  • D0692502MCC0 ()


  • Dental delivery system
Healgen (DrugConfirm) - 14 Panel Dip Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-1145
In Commercial Distribution

  • 00895330002585 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Nortriptyline IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6125A3C
In Commercial Distribution

  • 00895330002851 ()


  • Opiate/opiate metabolite IVD, reagent
  • 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
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
ESSILOR INTERNATIONAL
VRS001
In Commercial Distribution

  • 03615020000670 ()


  • Visual acuity light box
STEEL, ELECTRIC, THREE SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, ADJUSTABLE FOOT SECTION, SIDE PANEL, AND CASTERS
ARMEDICA MANUFACTURING CORP.
LAM350
In Commercial Distribution

  • B866MLAM3501 ()
  • B866PLAM3501 ()
LAM350

  • Examination/treatment table, line-powered
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the left
DE GÖTZEN SRL
XMT PAN 3D L
Not in Commercial Distribution

  • D804W09000100 ()
W0900010

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right
DE GÖTZEN SRL
XMT PAN 3D R
Not in Commercial Distribution

  • D804W09000040 ()
W0900004

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 37630039300105 2 x CT Exprès™ - Control Panel GTIN : 37630039300112
Bracco Injeneering SA
651207
In Commercial Distribution

  • 47630039300096 ()
651207

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0-A
In Commercial Distribution

  • 00816036027177 ()
  • 00816036026675 ()
SCP-21107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 8 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2387-0-A
In Commercial Distribution

  • 00816036027153 ()
  • 00816036026651 ()
SCP-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-71127-0
In Commercial Distribution

  • 00816036025128 ()
  • 00816036025289 ()
STATⅡ-71127-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50(OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920126
In Commercial Distribution

  • 00817815021478 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 Panel Cup - KCUR920120 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25 (CR/NI/OX/PH/SG)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920120
In Commercial Distribution

  • 00817815021416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 13 Panel Cup - KCUR920119 AMP1000/BAR 300/BUP10/BZO300/COC300/MAMP1000/MDMA500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920119
In Commercial Distribution

  • 00817815021386 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup-KCUR920115 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50 (OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920115
In Commercial Distribution

  • 00817815021355 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815021140 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 panel Cup - KCUR920080 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920080
In Commercial Distribution

  • 00817815021058 ()


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