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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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N/A - 00851725007153

Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7450
In Commercial Distribution

  • 00851725007153 ()
RNS-6803-7450

  • Centralized patient monitor

N/A - 00851725007146

No Audio Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-3464
In Commercial Distribution

  • 00851725007146 ()
RNS-6804-3464

  • Centralized patient monitor

N/A - 00851725007139

Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • 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

Vapotherm - 00841737105831

HVT 2.0 Buy Out Unit
VAPOTHERM, INC.
HVT-BUYOUT
In Commercial Distribution

  • 00841737105831 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual

Young - 00302732957226

Young Pointed Polisher, Latex Free, Firm, Blue Ribbed Exterior, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295722
In Commercial Distribution

  • 10302732957223 ()
  • 00302732957226 ()
295722

  • Dental polishing cup, single-use

Young - 00302732957042

Young Petite Prophy Cup, Latex Free, Firm, Short, Green Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295704
In Commercial Distribution

  • 10302732957049 ()
  • 00302732957042 ()
295704

  • Dental polishing cup, single-use

Young - 00302732954737

Young Dentek Prophy Cup, Latex Free, Soft, Regular, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
295473
In Commercial Distribution

  • 10302732954734 ()
  • 00302732954737 ()
295473

  • Dental polishing cup, single-use

Young - 00302730923001

Young Standard Prophy Brush, Firm, Long Flat Black Brush, Metal Latch Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
092300
In Commercial Distribution

  • 10302730923008 ()
  • 00302730923001 ()
092300

  • Dental-professional prophylaxis brush, single-use
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