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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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Elite022 LR6 Double BuccalTube Epic 24
ORTHO ORGANIZERS, INC.
900-12306E-24
In Commercial Distribution

  • 00190707133443 ()


  • Orthodontic metal band
Opti-Handles, 60cm (24") set of 2
Qfix
RT-4457
In Commercial Distribution

  • 00841962119900 ()
RT-4457

  • Indexed-immobilization patient positioning system
4/24/1/2SS, 4 Hook
PRYOR PRODUCTS
107-SST
Not in Commercial Distribution

  • 00007618875235 ()
107-SST

  • Freestanding/bed-attached intravenous pole
No Description
OSADA ELECTRIC CO.,LTD.
EXL-M40
In Commercial Distribution

  • 04580406860478 ()
3223

  • Dental laboratory power tool system
  • Line-powered dental drilling system
  • Dental power tool system, line-powered
No Description
OSADA ELECTRIC CO.,LTD.
XL-230
In Commercial Distribution

  • 04580406860461 ()
3192

  • Dental power tool system, line-powered
  • Dental laboratory power tool system
  • Line-powered dental drilling system
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
HemaPrompt fecal occult blood test
AERSCHER, INC
HP
In Commercial Distribution

  • 00693501000220 ()
  • 00069350100022 ()


  • Faecal occult blood IVD, reagent
HemaPrompt FG Fecal and Gastric Test Kit
AERSCHER, INC
HPFG
In Commercial Distribution

  • 00693501000152 ()
  • 00069350100015 ()


  • Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 22.5°C.
Temptime Corporation
CT36
In Commercial Distribution

  • 00852282007136 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 22.5°C.
Temptime Corporation
CT12
In Commercial Distribution

  • 00852282007129 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 22.5°C.
Temptime Corporation
CT24
In Commercial Distribution

  • 00852282007112 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 22.5°C.
Temptime Corporation
CT9
In Commercial Distribution

  • 00852282007105 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 22.5°C.
Temptime Corporation
CT6
In Commercial Distribution

  • 00852282007099 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 121 days at 22.5°C.
Temptime Corporation
CT4
In Commercial Distribution

  • 00852282007082 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C.
Temptime Corporation
CT3
In Commercial Distribution

  • 00852282007075 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 60 days at 22.5°C.
Temptime Corporation
CT2
In Commercial Distribution

  • 00852282007068 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 36 months at 5°C.
Temptime Corporation
F36
In Commercial Distribution

  • 00852282007051 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 24 months at 5°C.
Temptime Corporation
F24
In Commercial Distribution

  • 00852282007044 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
Temptime Corporation
F12
In Commercial Distribution

  • 00852282007037 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 48 cartridge
VERICOM CO., LTD.
VF324-SLFX
In Commercial Distribution

  • 08809254456678 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 12 cartridge
VERICOM CO., LTD.
VF360-SLFX
In Commercial Distribution

  • 08809254456661 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 2 cartridge, 6 Mixing Tips
VERICOM CO., LTD.
VF310-SLFX
In Commercial Distribution

  • 08809254456647 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 48 cartridge
VERICOM CO., LTD.
VF324-SLNX
In Commercial Distribution

  • 08809254456630 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 12 cartridge
VERICOM CO., LTD.
VF360-SLNX
In Commercial Distribution

  • 08809254456623 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Heavy-bodied consistency; Normal set; Catalyst 150ml x 1 Tube, Base 150ml x 1 Tube
VERICOM CO., LTD.
VF330-SHNT
In Commercial Distribution

  • 08809254456609 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 2 cartridge, 6 Mixing Tips
VERICOM CO., LTD.
VF310-SLNX
In Commercial Distribution

  • 08809254456593 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 1 cartridge
VERICOM CO., LTD.
VF305-SLFX
In Commercial Distribution

  • 08809254456562 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 1 cartridge
VERICOM CO., LTD.
VF305-SLNX
In Commercial Distribution

  • 08809254456555 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material ; Medium bodied Consistency ; Fast Set ; 50ml x 1 cartridge
VERICOM CO., LTD.
VF305-SMF0
In Commercial Distribution

  • 08809254456463 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material ; Medium bodied Consistency ; Normal Set ; 50ml x 1 cartridge
VERICOM CO., LTD.
VF305-SMN0
In Commercial Distribution

  • 08809254456456 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 48cartridges
VERICOM CO., LTD.
VF324-SLF0
In Commercial Distribution

  • 08809254456135 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 12cartridges
VERICOM CO., LTD.
VF360-SLF0
In Commercial Distribution

  • 08809254456128 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Fast set; 50ml x 2cartridges, 6 Mixing tips
VERICOM CO., LTD.
VF310-SLF0
In Commercial Distribution

  • 08809254456104 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 48cartridges
VERICOM CO., LTD.
VF324-SLN0
In Commercial Distribution

  • 08809254456098 ()


  • Silicone dental impression material
Hydrophilic Vinyl Polysiloxane Impression Material; Light-bodied consistency; Normal set; 50ml x 12cartridges
VERICOM CO., LTD.
VF360-SLN0
In Commercial Distribution

  • 08809254456081 ()


  • Silicone dental impression material
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