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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No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490-U
In Commercial Distribution

  • 00851725007269 ()
RNS-6804-7490-U

  • Centralized patient monitor
Remote Network Station with Dell OptiPlex 7480 23.8” All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7480-U
In Commercial Distribution

  • 00851725007252 ()
RNS-6803-7480-U

  • Centralized patient monitor
Speech Generating Device - Dell Venue Android - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278116 ()


  • Voice synthesizer/digitizer
Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer
DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable
Dell Swivel Toric Mark. W/Rotating Bezel
KATENA PRODUCTS, INC.
08-12120
In Commercial Distribution

  • 00841668119952 ()
08-12120

  • Corneal marker, reusable
Dell Fixed Toric Mark. W/ Rotating Bezel
KATENA PRODUCTS, INC.
08-12119
In Commercial Distribution

  • 00841668119945 ()
08-12119

  • Corneal marker, reusable
Dell Astigmatism Marker, 6 & 8mm Cord
KATENA PRODUCTS, INC.
08-121085
In Commercial Distribution

  • 00841668119853 ()

  • Length: 8 Millimeter
  • Length: 6 Millimeter
08-121085

  • Corneal marker, reusable
Dell Astigmatism Marker
KATENA PRODUCTS, INC.
08-12108
In Commercial Distribution

  • 00841668119846 ()
08-12108

  • Corneal marker, reusable
Dell Astigmatism Marker, (Nichamin)
KATENA PRODUCTS, INC.
08-121115
In Commercial Distribution

  • 00841668119891 ()
08-121115

  • Corneal marker, reusable
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