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
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose
Control Swabs intended for use only with the ID NOW RSV product.
Alere Scarborough, Inc.
435-080
In Commercial Distribution

  • 10811877010538 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs intended for use only with the Alere i RSV product.
Alere Scarborough, Inc.
435-080
Not in Commercial Distribution

  • 10811877010132 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
Not in Commercial Distribution

  • 10811877010118 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® AdV/hMPV/RV Controls Kit.
Hologic, Inc.
AMR CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509320 ()
PRD-04338

  • Multiple-genus respiratory virus nucleic acid IVD, control
The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).
Hologic, Inc.
AMR KIT, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509290 ()
PRD-04330

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605202
In Commercial Distribution

  • 00690286000506 ()
  • 10690286000503 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Amphetamine, Benzodiazepines, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605103
In Commercial Distribution

  • 10690286000442 ()
  • 00690286000445 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Amphetamine, Benzodiazepines, Cocaine, Methamphetamine, Opiates, Oxycodone, and THC (Cannabinoids) drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
600686
Not in Commercial Distribution

  • 10690286000381 ()
  • 00690286000384 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel One Step DOA Cup (10.11) - COC(300) AMP(1000) MET(1000) THC(50) EDDP(300) MOP(300) OPI(2000) OXY(100) BZO(300) BUP(10)
BTNX Inc
D10.11-1V
In Commercial Distribution

  • 00722066004784 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Dual Light with Single Flat Panel Monitor, No 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

  • 00724995172831 ()
LES02NCND

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

  • 00724995172824 ()
LES02NC02

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

  • 00724995172817 ()
LES02NC01

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No 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

  • 00724995175832 ()
LES13NCND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No 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

  • 00724995175597 ()
LES11NCND

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

  • 00724995175580 ()
LES11NC02

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

  • 00724995175573 ()
LES11NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid 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

  • 00724995175986 ()
LES56INNDT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Hybrid 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

  • 00724995175979 ()
LES56IN02T

  • 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, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175962 ()
LES56IN01T

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

  • 00724995175825 ()
LES13NC02

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

  • 00724995175818 ()
LES13NC01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single 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

  • 00724995173579 ()
LES04IN02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single 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

  • 00724995173562 ()
LES04IN01T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single 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

  • 00724995173548 ()
LES04NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single 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

  • 00724995173531 ()
LES04NC01

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

  • 00724995173401 ()
LEH04INND

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

  • 00724995173340 ()
LES24INNDT

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

  • 00724995173326 ()
LES24IN01T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, No 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

  • 00724995173319 ()
LES24NCND

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

  • 00724995173302 ()
LES24NC02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the left configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN L CEPH R 3D READY
Not in Commercial Distribution

  • D804W09002400 ()
W0900240

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN R CEPH L 3D READY
Not in Commercial Distribution

  • D804W09002390 ()
W0900239

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT CEPH version including one PAN sensor,with control panel on the right side including one removable ceph sensor ceph arm on the right
DE GÖTZEN SRL
XMT PAN 3D R CEPH R
Not in Commercial Distribution

  • D804W09002310 ()
W0900231

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

  • D804W09000060 ()
W0900006

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
12- Drug Test Panel - 25/kit (12.36) - AMP1000 BAR300 BZO300 COC300 MDMA500 MET1000 OPI2000 PCP25 THC50 MTD300 OXY100 PPX300. For the detection of drugs in human urine.
BTNX Inc
D12.36-1P29-25
In Commercial Distribution

  • 00722066005644 ()
  • 10722066005641 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, PCP25, PPX300, TCA1000, THC50 w/ SVT OX/SG/pH
Instant Technologies, Inc.
ABTDUAW114704D
In Commercial Distribution

  • 30817405023883 ()
  • 00817405023882 ()
  • 10817405023889 ()
ABTDUAW114704D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50 w/ SVT OX/SG/Ph
Instant Technologies, Inc.
ABTDUAW114703C
In Commercial Distribution

  • 30817405023845 ()
  • 00817405023844 ()
  • 10817405023841 ()
ABTDUAW114703C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel CLIA Waived Test Cup W/AD, AMP/BARB/BZO/BUP/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATII-43147-0-A
In Commercial Distribution

  • 00816036025340 ()
  • 00816036025357 ()
STATII-43147-0-A

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