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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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Polyaxial screw,w/o cannulation 5.5/20mm
mahe medical gmbh
PSS09-15520
In Commercial Distribution

  • EMAHPSS09155201 ()
  • EMAHPSS09155200 ()
PSS09-15520

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/60mm
mahe medical gmbh
PSS08-4560
In Commercial Distribution

  • EMAHPSS0845601 ()
  • EMAHPSS0845600 ()
PSS08-4560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/55mm
mahe medical gmbh
PSS08-4555
In Commercial Distribution

  • EMAHPSS0845551 ()
  • EMAHPSS0845550 ()
PSS08-4555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/50mm
mahe medical gmbh
PSS08-4550
In Commercial Distribution

  • EMAHPSS0845501 ()
  • EMAHPSS0845500 ()
PSS08-4550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/45mm
mahe medical gmbh
PSS08-4545
In Commercial Distribution

  • EMAHPSS0845451 ()
  • EMAHPSS0845450 ()
PSS08-4545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/35mm
mahe medical gmbh
PSS08-4535
In Commercial Distribution

  • EMAHPSS0845351 ()
  • EMAHPSS0845350 ()
PSS08-4535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/30mm
mahe medical gmbh
PSS08-4530
In Commercial Distribution

  • EMAHPSS0845301 ()
  • EMAHPSS0845300 ()
PSS08-4530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw, w/o cannulation, 4.5mm/25mm
mahe medical gmbh
PSS08-4525
In Commercial Distribution

  • EMAHPSS0845251 ()
  • EMAHPSS0845250 ()
PSS08-4525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/60mm
mahe medical gmbh
PSR11-7560
In Commercial Distribution

  • EMAHPSR1175601 ()
  • EMAHPSR1175600 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 7.5 Millimeter
PSR11-7560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/55mm
mahe medical gmbh
PSR11-7555
In Commercial Distribution

  • EMAHPSR1175551 ()
  • EMAHPSR1175550 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55.0 Millimeter
PSR11-7555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/50mm
mahe medical gmbh
PSR11-7550
In Commercial Distribution

  • EMAHPSR1175501 ()
  • EMAHPSR1175500 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50.0 Millimeter
PSR11-7550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial screw reduct., w/o cannulation 7.5mm/45mm
mahe medical gmbh
PSR11-7545
In Commercial Distribution

  • EMAHPSR1175451 ()
  • EMAHPSR1175450 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 45.0 Millimeter
PSR11-7545

  • Bone-screw internal spinal fixation system, non-sterile
Set screw f.polyaxial screws
mahe medical gmbh
CHM01-11
In Commercial Distribution

  • EMAHCHM01111 ()
  • EMAHCHM01110 ()
CHM01-11

  • Bone-screw internal spinal fixation system, non-sterile
Set screw w.plate f.polyaxial screws
mahe medical gmbh
CHM01-10
In Commercial Distribution

  • EMAHCHM01101 ()
  • EMAHCHM01100 ()

  • Width: 6.6 Millimeter
CHM01-10

  • Bone-screw internal spinal fixation system, non-sterile
Suction Tubing Set 2 m
Assamed GmbH - Medizinbedarf
05354500
In Commercial Distribution

  • 14251783104185 ()
  • 04251783104188 ()
  • 24251783104182 ()

  • Length: 2 Meter


  • Surgical irrigation tubing set, single-use
03 pieces sets for embryo transfer
LABORATOIRE CCD
T.D.T.®SET
In Commercial Distribution

  • 03700111425064 ()
  • 03700111400061 ()

  • Catheter Length: 26.4 Centimeter
  • Outer Diameter: 0.1 Centimeter
1308000

  • Assisted reproduction transfer catheter trial
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
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