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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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Remote Network Station - 00851725007269

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 - 00851725007252

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

Lingraphica - 00850042278116

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

  • 00850042278116 ()


  • Voice synthesizer/digitizer

Lingraphica - 00850042278109

Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer

DELL FIXATION RING - 00841668128497

DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable

Mrk, Ocular - 00841668119952

Dell Swivel Toric Mark. W/Rotating Bezel
KATENA PRODUCTS, INC.
08-12120
In Commercial Distribution

  • 00841668119952 ()
08-12120

  • Corneal marker, reusable

Mrk, Ocular - 00841668119945

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

  • 00841668119945 ()
08-12119

  • Corneal marker, reusable

Mrk, Ocular - 00841668119853

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

Mrk, Ocular - 00841668119846

Dell Astigmatism Marker
KATENA PRODUCTS, INC.
08-12108
In Commercial Distribution

  • 00841668119846 ()
08-12108

  • Corneal marker, reusable

Mrk, Ocular - 00841668119891

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

  • 00841668119891 ()
08-121115

  • Corneal marker, reusable
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