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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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Catphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Service.
Providus Holdings, Inc.
CTP500
In Commercial Distribution

  • 00812266030024 ()


  • CT phantom, test object
COPDGene Lung Phantom ll
Providus Holdings, Inc.
CCT162
In Commercial Distribution

  • 00812266030017 ()


  • CT phantom, test object
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object
No Description
SUN NUCLEAR CORP.
2823
In Commercial Distribution

  • B13628230 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
200
In Commercial Distribution

  • B1362000 ()


  • CT phantom, test object
High Resolution Module
Providus Holdings, Inc.
CTP764
In Commercial Distribution

  • 00812266031403 ()
CTP764

  • CT phantom, test object
SW D00U024 CARELINK SS LINQ II ICM
MEDTRONIC, INC.
D00U024
In Commercial Distribution

  • 00763000754914 ()


  • Implantable cardiac device management application software
SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software
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