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 ELITE SIZE 1 WITH 6' CABLE ATTACHED
SIRONA DENTAL, INC.
B2401041
In Commercial Distribution

  • D764B24010411 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S0, 3FT
SIRONA DENTAL, INC.
B1307002
In Commercial Distribution

  • D764B13070021 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S0, 9FT
SIRONA DENTAL, INC.
B1307001
In Commercial Distribution

  • D764B13070011 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S0, 6FT
SIRONA DENTAL, INC.
B1307000
In Commercial Distribution

  • D764B13070001 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE G2 S2 SENSOR
SIRONA DENTAL, INC.
B1217200
In Commercial Distribution

  • D764B12172000 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 - 3' REPLACEMENT
SIRONA DENTAL, INC.
B1217053
In Commercial Distribution

  • D764B12170531 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 - 9' REPLACEMENT
SIRONA DENTAL, INC.
B1217052
In Commercial Distribution

  • D764B12170521 ()


  • Dental digital imaging sensor, intraoral
SCHICK ELITE SIZE 2 - 6' REPLACEMENT
SIRONA DENTAL, INC.
B1217051
In Commercial Distribution

  • D764B12170511 ()


  • Dental digital imaging sensor, intraoral
SCHICK REPLACEABLE CABLE 9FT
SIRONA DENTAL, INC.
B1209156
In Commercial Distribution

  • D764B12091561 ()


  • Dental digital imaging sensor, intraoral
SCHICK REPLACEABLE CABLE KIT 6FT
SIRONA DENTAL, INC.
B1209120
In Commercial Distribution

  • D764B12091201 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR S2
SIRONA DENTAL, INC.
B1207200
In Commercial Distribution

  • D764B12072000 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S2, 6FT
SIRONA DENTAL, INC.
B1207000
In Commercial Distribution

  • D764B12070001 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR S1
SIRONA DENTAL, INC.
B1107200
In Commercial Distribution

  • D764B11072000 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S1, 3FT
SIRONA DENTAL, INC.
B1107002
In Commercial Distribution

  • D764B11070021 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S1, 9FT
SIRONA DENTAL, INC.
B1107001
In Commercial Distribution

  • D764B11070011 ()


  • Dental digital imaging sensor, intraoral
CDR ELITE SENSOR SHIP KIT S1, 6FT
SIRONA DENTAL, INC.
B1107000
In Commercial Distribution

  • D764B11070001 ()


  • Dental digital imaging sensor, intraoral
UNIVERSAL RING ADHESIVE HOLDER SYSTEM STARTER KIT
SIRONA DENTAL, INC.
B1074330
In Commercial Distribution

  • D764B10743301 ()


  • Dental x-ray film holder, reusable
SCHICK AIMRIGHT - PERIAPICAL AUTOCLAVABLE HOLDERS - S2 (4) YELLOW
SIRONA DENTAL, INC.
B1074254
In Commercial Distribution

  • D764B10742541 ()


  • Dental x-ray film holder, reusable
SCHICK AIMRIGHT - ANTERIOR AUTOCLAVABLE HOLDER S2 (2) WHITE
SIRONA DENTAL, INC.
B1074253
In Commercial Distribution

  • D764B10742531 ()
  • D764B10742030 ()


  • Dental x-ray film holder, reusable
SCHICK AIMRIGHT - VERTICAL BITEWING AUTOCLAVABLE HOLDER S2 (2) BLUE
SIRONA DENTAL, INC.
B1074252
In Commercial Distribution

  • D764B10742521 ()
  • D764B10742020 ()


  • Dental x-ray film holder, reusable
SCHICK AIMRIGHT - HORIZONTAL BITEWING AUTOCLAVABLE HOLDER S2 (2) BLUE
SIRONA DENTAL, INC.
B1074251
In Commercial Distribution

  • D764B10742511 ()
  • D764B10740500 ()


  • Dental x-ray film holder, reusable
SCHICK AIMRIGHT AUTOCLAVABLE STARTER KIT - SIZE 2
SIRONA DENTAL, INC.
B1074230
In Commercial Distribution

  • D764B10742301 ()


  • Dental x-ray film holder, reusable
XIOS AE USB Size 2 270cm Rep
SIRONA DENTAL, INC.
6724889
In Commercial Distribution

  • D76467248891 ()


  • Dental digital imaging sensor, intraoral
XIOS AE USB Size 0 270cm Rep
SIRONA DENTAL, INC.
6724863
In Commercial Distribution

  • D76467248631 ()


  • Dental digital imaging sensor, intraoral
XIOS AE USB Size 1 270cm Spare
SIRONA DENTAL, INC.
6724848
In Commercial Distribution

  • D76467248481 ()


  • Dental digital imaging sensor, intraoral
XIOS AE Sensor USB Size 2 270cm Cable
SIRONA DENTAL, INC.
6724764
In Commercial Distribution

  • D76467247641 ()


  • Dental digital imaging sensor, intraoral
XIOS AE Sensor USB Size 0 270cm Cable
SIRONA DENTAL, INC.
6724749
In Commercial Distribution

  • D76467247491 ()


  • Dental digital imaging sensor, intraoral
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
The HarmonyAIR Dual Light with 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

  • 00724995172800 ()
LES02INND

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

  • 00724995172787 ()
LES02IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAir E-Series High Definition Dual Light, Single Flat Panel Monitor, Auxiliary 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

  • 00724995172145 ()
LEH03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The HarmonyAIR E-Series Spindle Hybrid Single Light Dual Flat Panel Monitor High Definition is a ceiling supported lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995170981 ()
LEH000018

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

  • 00724995168667 ()
LEH56

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