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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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Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-115
In Commercial Distribution

  • 00863152000324 ()


  • Limited-view-field CT system
No Description
Freudenberg Medical, LLC
IN 4063
In Commercial Distribution

  • 00848253004020 ()
IN 4063

  • Airway device cleaning utensil, invasive
No Description
Freudenberg Medical, LLC
IN 4062
In Commercial Distribution

  • 00848253004013 ()
IN 4062

  • Airway device cleaning utensil, invasive
No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)
No Description
Freudenberg Medical, LLC
IN 1605-LESL
In Commercial Distribution

  • 00813307013914 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive
No Description
Freudenberg Medical, LLC
IN 2005-LESL
In Commercial Distribution

  • 00813307013907 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive
No Description
Freudenberg Medical, LLC
IN 1609-SL
In Commercial Distribution

  • 00813307013877 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
No Description
Freudenberg Medical, LLC
IN 1607-SL
In Commercial Distribution

  • 00813307013860 ()


  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
No Description
Freudenberg Medical, LLC
IN 1605-SL
In Commercial Distribution

  • 00813307013853 ()


  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
No Description
Freudenberg Medical, LLC
IN 4066
In Commercial Distribution

  • 00813307014744 ()
  • 00848253002682 ()


  • Airway device cleaning utensil, invasive
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