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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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Clear Guide CORE - B201CGCORE130

The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer

Amadeo M-DR mini - 04250802902897

The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging.
Oehm und Rehbein GmbH
Amadeo M-DR mini with XenOR flat panel
Not in Commercial Distribution

  • 04250802902927 ()
  • 04250802902897 ()

  • Weight: 79 Kilogram
AM1622

  • Mobile basic diagnostic x-ray system, digital

Acuitas - 04260364751024

PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Curetis GmbH
Acuitas AMR Gene Panel PCR Plate Kit
Not in Commercial Distribution

12001

  • Microplate IVD
  • Assay adhesive sealing/fixation film IVD

Rapid Response - 00722066004906

One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi
BTNX Inc
D12.11.1-1VA
In Commercial Distribution

  • 00722066004906 ()


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

ORLocate - 00724995220631

The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
Steris Corporation
ORLocate Components Pack
Not in Commercial Distribution

  • 00724995220631 ()
ORL10017049

  • Radio-frequency identification reader

HarmonyAIR - 00724995214265

The E-Series High Density Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214265 ()
LEH14NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995214258

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214258 ()
LEH14NC02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995214241

The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214241 ()
LEH14NC01T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

VERDICT®-II - 00690286000247

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, and Cocaine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601643
Not in Commercial Distribution

  • 10690286000244 ()
  • 00690286000247 ()


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

VERDICT®-II - 00690286000148

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, and Cocaine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601593
Not in Commercial Distribution

  • 10690286000145 ()
  • 00690286000148 ()


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

CSI - 00850798007664

CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-8105
In Commercial Distribution

  • 00850798007688 ()
  • 00850798007671 ()
  • 00850798007664 ()


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

Alpine BioMed - 05704736017176

"Keypoint Focus Notebook System, ITA Including: - Notebook PC with Keypoint software - Keypoint Focus Main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071106
Not in Commercial Distribution

  • 05704736017176 ()


  • Electromyograph

Alpine BioMed - 05704736017183

"Keypoint Focus Notebook System, DAN Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071143
Not in Commercial Distribution

  • 05704736017183 ()


  • Electromyograph

Alpine BioMed - 05704736017169

"Keypoint Focus Notebook System, NLD Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071105
Not in Commercial Distribution

  • 05704736017169 ()


  • Electromyograph

Alpine BioMed - 05704736017152

"Keypoint Focus Notebook System, SPA Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071104
Not in Commercial Distribution

  • 05704736017152 ()


  • Electromyograph

Alpine BioMed - 05704736017145

"Keypoint Focus Notebook System, DEU Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A071103
Not in Commercial Distribution

  • 05704736017145 ()


  • Electromyograph

Alpine BioMed - 05704736017091

"Keypoint Focus Notebook System, ENG Including: - Notebook PC with Keypoint software - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators - System kit"
Alpine Biomed ApS
9033A0711BV
Not in Commercial Distribution

  • 05704736017091 ()


  • Electromyograph

U-Screen - 00858998006074

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/BUP/MDMA/MTD/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-10MOB-300
Not in Commercial Distribution

  • 00858998006074 ()
USSCupA-10MOB-300

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

U-Screen - 00858998006067

U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Tech Subsidiary Acquisition
USSCupA-10M
Not in Commercial Distribution

  • 00858998006067 ()
USSCupA-10M

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

Alere iCup Dx Pro 2 - 00858945006812

iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
Instant Technologies, Inc.
I-DXP-167-02
In Commercial Distribution

  • 00858945006812 ()
I-DXP-167-02

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

HarmonyAIR - 00724995170660

The HarmonyAIR E-Series 59-inch Auxiliary Arm with Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995170660 ()
LEH0070

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995168612

The HarmonyAIR E-Series High Definition Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168612 ()
LEH11

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

ORLocate - 00724995245290

The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
STERIS CORPORATION
ORLocate Components Pack
In Commercial Distribution

ORL10017049

  • Radio-frequency identification reader

HarmonyAIR - 00724995200183

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200183 ()
LAH04INNDTA

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995200176

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200176 ()
LAH04IN02TA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995200169

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200169 ()
LAH04IN01TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995200152

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200152 ()
LAH04NCNDA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995200145

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200145 ()
LAH04NC02A

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995200138

The A-Series Single High Definition Light 35-inch, 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

  • 00724995200138 ()
LAH04NC01A

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount

HarmonyAIR - 00724995199944

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199944 ()
LAH24INNDTA

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995199937

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199937 ()
LAH24IN02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199920

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199920 ()
LAH24IN01TA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199913

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199913 ()
LAH24NCNDA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199906

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199906 ()
LAH24NC02A

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light

HarmonyAIR - 00724995199890

The A-Series High Definition Single Light 43-inch, 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

  • 00724995199890 ()
LAH24NC01A

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199494

The A-Series High Definition Dual Light, Single Flat Panel Monitor, No Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199494 ()
LAH02NCNDTA

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995199487

The A-Series High Definition Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube, Non-Camera, Tandem Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199487 ()
LAH02NC02TA

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995199470

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

  • 00724995199470 ()
LAH02NC01TA

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995199173

The G5 Dual Light with Single Flat Panel Monitor, HD Camera Ready, Connect Point and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995199173 ()
LGH51CPT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995192464

The G5 Dual Light with Dual Single Flat Panel Monitor, High Density Camera Ready with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995192464 ()
LGH51T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
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