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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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RAPID - 07290101366041

WS, Dell T3600 V8.3 US
Given Imaging, Inc.
FGS-0576
Not in Commercial Distribution

  • 07290101366041 ()


  • Video capsule endoscopy system antenna

ManoScan - 07290101365914

Notebook, Dell E6440 Win 7
Given Imaging, Inc.
FGS-0570
In Commercial Distribution

  • 07290101365914 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365877

Dell 3020 Win XP GT
Given Imaging, Inc.
FGS-8046
In Commercial Distribution

  • 07290101365877 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365860

Dell 3020 Win 7
Given Imaging, Inc.
FGS-8045
In Commercial Distribution

  • 07290101365860 ()


  • Manometric gastrointestinal motility analysis system

NA - 07290101365655

Monitor, Dell P2214H 22 LED
Given Imaging, Inc.
FGS-0558
In Commercial Distribution

  • 07290101365655 ()


  • Manometric gastrointestinal motility analysis system

RAPID - 07290101364467

WS, Dell T3400, OUS RFB
Given Imaging, Inc.
RFB-0336
Not in Commercial Distribution

  • 07290101364467 ()
RFB-0336

  • Video capsule endoscopy system antenna

RAPID - 07290101364207

WS, Dell T3400, SCA
Given Imaging, Inc.
FGS-0487
In Commercial Distribution

  • 07290101364207 ()


  • Video capsule endoscopy system application software

RAPID - 07290101364184

WS, Dell T3400, US
Given Imaging, Inc.
FGS-0485
In Commercial Distribution

  • 07290101364184 ()


  • Video capsule endoscopy system application software

Ambler Surgical - 00190660104245

Dell LRI astigmatism marker (Nichamin Nomogram), 4 3/4'', 40/60/80 degree markings, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Nichamin Nomogram)
In Commercial Distribution

  • 00190660104245 ()
8302T

  • Scleral marker, reusable

Ambler Surgical - 00190660104238

Dell LRI astigmatism marker (Gills Nomogram), 4 3/4'', marks chord length of 6.0mm and 8.0mm, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Gills Nomogram)
In Commercial Distribution

  • 00190660104238 ()
8301T

  • Scleral marker, reusable
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