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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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Dimension® clinical chemistry system T/F PSA Calibrator - 00842768013751

Heterogeneous Immunoassay Module Total/Free Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10445031
In Commercial Distribution

  • 00842768013751 ()
RC452

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® System PSA CAL - 00842768024214

Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

BD SurePath™ Collection Vial - 10382904914520

BD SurePath™ Collection Vial
BECTON, DICKINSON AND COMPANY
491452
In Commercial Distribution

  • 30382904914524 ()
  • 10382904914520 ()
  • 00382904914523 ()
491452

  • Cytology specimen container IVD, transport buffer

BD SurePath™ Collection Vial Kit 500 - 10382904912533

BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)
TRIPATH IMAGING, INC.
491253
Not in Commercial Distribution

  • 10382904912533 ()
  • 00382904912536 ()
  • 30382904912537 ()
491253

  • Cytology specimen container IVD, transport buffer

SurePath Preservative Fluid Collection Vial - 10382904905276

SurePath® GYN Preservative Vial Kit: 10 mL SurePath® Preservative Fluid Collection Vials (500)
BECTON, DICKINSON AND COMPANY
490527
Not in Commercial Distribution

  • 10382904905276 ()
  • 00382904905279 ()
  • 30382904905270 ()

  • Width: 44.2 Centimeter
  • Length: 44.2 Centimeter
  • Height: 8.3 Centimeter
490527

  • Cytology specimen container IVD, transport buffer

Paradise® Catheter - 00810008950043

PRDS-068-02 Paradise® Catheter 8mm
Recor Medical, Inc.
PRDS-068-02
In Commercial Distribution

  • 00810008950043 ()

  • Balloon Diameter: 8 Millimeter
PRDS-068-02

  • Renal denervation ultrasound system catheter

ThinPrep Pap Test - 15420045504011

No Description
Hologic, Inc.
ThinPrep Pap Test Physician Kit
Not in Commercial Distribution

  • 15420045504011 ()


  • Cytology specimen container IVD, transport buffer

ThinPrep Pap Test - 15420045504004

No Description
Hologic, Inc.
ThinPrep Pap Test Physician Kit
Not in Commercial Distribution

  • 15420045504004 ()


  • Cytology specimen container IVD, transport buffer

Progensa - 15420045500822

No Description
Hologic, Inc.
URINE SPECIMENT TRANSPORT TUBES
Not in Commercial Distribution

  • 15420045500822 ()
303550

  • Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

Progensa - 15420045500761

No Description
Hologic, Inc.
PSA
Not in Commercial Distribution

  • 15420045500761 ()
302357

  • Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)
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