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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The Touch Panel Control Unit Primary Dual Secondary Single Remote Power Module M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165581 ()
LM0012

  • Medical monitor/light mount
The Single High Density M5 without Control with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166533 ()
LMH06NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Air Dual M7/M5 High Density with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166038 ()
LMH08NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The Dual High Density M5 without Control with Single Flat Panel Monitor Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165697 ()
LMH02NT

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The Touch Panel Control Unit Primary Dual Secondary Dual Remote Power Module M-Series is used with the HarmonyAIR M-Series Suspension System.
STERIS CORPORATION
M-Series Suspension
In Commercial Distribution

  • 00724995165598 ()
LM0013

  • Medical monitor/light mount
The G5 Dual Light with Single Flat Panel Monitor Mount, No Camera, Fixed is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995192136 ()
LG11F

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The G5 Single Light with Single Flat Panel Monitor Mount, Non Camera, Fixed is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191993 ()
LG07F

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191399 ()
LM24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5, Single Package with Single Flat Panel Monitor Mount, No Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191382 ()
LM04T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5, Single Package with Single Flat Panel Monitor Mount, without Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191375 ()
LM04

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M7 Single High Density Package No Hub, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191757 ()
LMH09

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The M5, Dual Package with Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191436 ()
LM02

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The M5, Single Package with Single Flat Panel Monitor Mount, with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191405 ()
LM24T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, No Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176167 ()
LES57NCND

  • Medical monitor/light mount
The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 20-inch Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176150 ()
LES57NC02

  • Medical monitor/light mount
The E-Series with Dual Flat Panel Monitor Arm, 67-inch Arm, 13-inch Drop Tube, No Camera is a ceiling supported suspension system.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995176143 ()
LES57NC01

  • Medical monitor/light mount
The A-Series Single Light 35-inch, Single Flat Panel Monitor, No Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200244 ()
LAS04INNDA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The A-Series Single Light 35-inch, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200237 ()
LAS04IN02A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The A-Series Single Light 35-inch, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200220 ()
LAS04IN01A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The A-Series Single Light 43-inch, Single Flat Panel Monitor, NO Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995200008 ()
LAS24INNDA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
The A-Series Single Light 43-inch, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199999 ()
LAS24IN02A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The A-Series Single Light 43-inch, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199982 ()
LAS24IN01A

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

  • 00724995199586 ()
LAS02INNDTA

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

  • 00724995199579 ()
LAS02IN02TA

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

  • 00724995199562 ()
LAS02IN01TA

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

  • 00724995199555 ()
LAS02NCNDA

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

  • 00724995199548 ()
LAS02NC02A

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

  • 00724995199531 ()
LAS02NC01A

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The G5 Dual Light with Single Flat Panel Monitor, Non-Camera Ready, Single Cardanic is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995199197 ()
LG41

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

  • D804W09002320 ()
W0900232

  • 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
DE GÖTZEN SRL
XMT PAN L CEPH R
Not in Commercial Distribution

  • D804W09000090 ()
W0900009

  • Stationary panoramic/tomographic dental x-ray system, digital
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.39-2FC1E)- AMP50, COC20, MET50, OPI40, PCP10. For employment and insurance testing.
BTNX Inc
D5.39-2FC1E
In Commercial Distribution

  • 00722066006771 ()
  • 10722066006778 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.2-2FC1E)- TAMP50, COC20, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D5.2-2FC1E
In Commercial Distribution

  • 00722066006764 ()
  • 10722066006761 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.1.1-2FC1E)-THC40 COC20 AMP50 MET50 OPI40. For employment and insurance testing.
BTNX Inc
D5.1.1-2FC1E
In Commercial Distribution

  • 10722066006617 ()
  • 00722066006610 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single/Multi DOA Panel MOR 2000 (Urine)- OXY100, MDMA500, COC300, BZO300, EDDP300, BUP10, MET1000, OPI2000, AMP1000, THC50-25 tests/ kit
BTNX Inc
D10.43-1P29-25
In Commercial Distribution

  • 00722066008256 ()
  • 10722066008253 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<COC>+<AMP>+(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP)
Instant Technologies, Inc.
DUE-197-341
In Commercial Distribution

  • 10817405024077 ()
  • 00817405024070 ()
DUE-197-341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-7MT-W
Not in Commercial Distribution

  • 00816565020243 ()
IMCA-7MT-W

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