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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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HarmonyAIR - 00724995173562

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

HarmonyAIR - 00724995173548

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

HarmonyAIR - 00724995173531

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

HarmonyAIR - 00724995173401

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

HarmonyAIR - 00724995173340

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

HarmonyAIR - 00724995173326

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

HarmonyAIR - 00724995173319

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

HarmonyAIR - 00724995173302

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

Rapid Response - 00722066004784

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

HarmonyAIR - 00724995172831

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

HarmonyAIR - 00724995172824

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

HarmonyAIR - 00724995172817

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

X-MIND trium - D804W09002400

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 - D804W09002390

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 - D804W09002310

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 - D804W09000060

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

Bicycle Health - 10850013035202

Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-BH9-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035205 ()
  • 10850013035202 ()
ID-BH9-ADULT-1-AZ25

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

Identify Health - 10850013035196

Identify Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box
MEDICAL DISTRIBUTION GROUP INC
ID-H9-ADULT-1-AZ25
In Commercial Distribution

  • 00850013035199 ()
  • 10850013035196 ()
ID-H9-ADULT-1-AZ25

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

iCup® - 10817405021335

iCup® E&I Urine Test 11 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/BAR300/BZO300/BUP10/COC300/MTD300/MET1000/MDMA500/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
DPG-1117-141
In Commercial Distribution

  • 00817405021338 ()
  • 10817405021335 ()
DPG-1117-141

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

Rapid Response - 10722066005641

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
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