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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Schick AE Sensor S0 Front Can Attach
SIRONA DENTAL, INC.
100006074
In Commercial Distribution

  • D7641000060740 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S1 Front Can Attach
SIRONA DENTAL, INC.
100006040
In Commercial Distribution

  • D7641000060400 ()


  • Dental digital imaging sensor, intraoral
Schick AE Sensor S2 Front Can Attach
SIRONA DENTAL, INC.
100006036
In Commercial Distribution

  • D7641000060360 ()


  • Dental digital imaging sensor, intraoral
Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200500
In Commercial Distribution

  • E31584682005000 ()


  • Stationary panoramic dental x-ray system, analogue
Digital Panoramic X-Ray Unit, including patient positioning items
BLUO ELECTRONICS SRL
8468200300
In Commercial Distribution

  • E31584682003000 ()


  • Stationary panoramic dental x-ray system, digital
Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200100
In Commercial Distribution

  • E31584682001000 ()


  • Stationary panoramic dental x-ray system, analogue
Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468201200
In Commercial Distribution

  • E31584682012000 ()


  • Stationary panoramic dental x-ray system, analogue
Size 2
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344701 ()
16000004525

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
EAGLE S
In Commercial Distribution

  • 07899581344695 ()
16000004524

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340727 ()
16000004374

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340697 ()
16000004373

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340284 ()
16000004138

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340277 ()
16000004137

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340260 ()
16000004136

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340253 ()
16000004135

  • Dental digital imaging sensor, intraoral
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-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
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-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)
MERCEDES MEDICAL, LLC
TNR CDOA7125A3
In Commercial Distribution

  • 00850011007112 ()
  • 10850011007119 ()
  • 20850011007116 ()
TNR CDOA7125A3

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group 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
Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44
STANDARD TEXTILE CO., INC.
95301682
In Commercial Distribution

  • 00634916000016 ()
  • 10634916000013 ()
95301682

  • Patient surgical drape, reusable
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)
Instant Technologies, Inc.
I-DXP-177-01
In Commercial Distribution

  • 00858945006836 ()
I-DXP-177-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Phencyclidine, and Amphetamine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605200
In Commercial Distribution

  • 00690286000483 ()
  • 10690286000480 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Cocaine, Amphetamine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605104
In Commercial Distribution

  • 00690286000452 ()
  • 10690286000459 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601599
In Commercial Distribution

  • 00690286000346 ()
  • 10690286000343 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Benzodiazepines drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601638
Not in Commercial Distribution

  • 10690286000213 ()
  • 00690286000216 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, and Phencyclidine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601594
Not in Commercial Distribution

  • 10690286000152 ()
  • 00690286000155 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731958 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731941 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH
Medical Disposables Corp
MDC-14125A3A
In Commercial Distribution

  • 00860001731934 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The HarmonyAIR Single Light, with Dual 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

  • 00724995175801 ()
LES13INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175795 ()
LES13IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175788 ()
LES13IN01

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

  • 00724995175566 ()
LES11INND

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175559 ()
LES11IN02

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175542 ()
LES11IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light 43-inchwith Single Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995173272 ()
LES24IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The A-Series High Definition Single Light 43-inch, 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

  • 00724995199975 ()
LAH24NCNDTA

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

  • 00724995192303 ()
LGH38T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The A-Series Single High Definition Light 35-inch, 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

  • 00724995200213 ()
LAH04NCNDTA

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
The A-Series Single High Definition Light 35-inch, 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

  • 00724995200206 ()
LAH04NC02TA

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
The A-Series Single High Definition Light 35-inch, 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

  • 00724995200190 ()
LAH04NC01TA

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