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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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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

PillCam - 07290110360221

PillCam™ WS v9 Dell T5810, USA
Given Imaging, Inc.
FGS-0640
In Commercial Distribution

  • 07290110360221 ()


  • Video capsule endoscopy system application software

Planning station ROSA BRain - 03760244032799

planning station DELL 7520 QUERTY power plug B for Rosa Brain 3.0.1
MEDTECH
164017
Not in Commercial Distribution

  • 03760244032799 ()
ROSAS00517

  • Neurological stereotactic surgery system

PLANNING STATION - ROSA ONE - USA - 00889024663282

Planning station DELL 3580 Qwerty power plug B for Rosa One 3.1.7
MEDTECH
164056
In Commercial Distribution

  • 00889024663282 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system
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