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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 - 07290101366058

WS, Dell T3600 V8.5 US
Given Imaging, Inc.
FGS-0577
In Commercial Distribution

  • 07290101366058 ()


  • Video capsule endoscopy system application software

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

Sectra Digital Pathology Module - 07350092810593

For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.2
In Commercial Distribution

  • 07350092810593 ()


  • Pathology information system
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