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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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CATH AFAPRO23 AFA PRO 23 US MVC
MEDTRONIC, INC.
AFAPRO23
In Commercial Distribution

  • 00763000707774 ()

  • Catheter Gauge: 10.5 French
  • Catheter Working Length: 95.0 Centimeter
  • Catheter tip width 23 mm


  • Cardiac cryosurgical system catheter
CATH AFAPRO23 AFA PRO 23 US PB
MEDTRONIC, INC.
AFAPRO23
In Commercial Distribution

  • 00763000197766 ()

  • Catheter tip width 23 mm
  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ
MEDTRONIC, INC.
20MRK
In Commercial Distribution

  • 00763000228699 ()


  • Catheter/overtube balloon inflator, single-use
CATH AFAPRO28 AFA PRO 28 US
MEDTRONIC, INC.
AFAPRO28
In Commercial Distribution

  • 00763000245436 ()

  • Catheter tip width 28 mm
  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
CATH AFAPRO23 AFA PRO 23 US
MEDTRONIC, INC.
AFAPRO23
Not in Commercial Distribution

  • 00763000245412 ()

  • Catheter tip width 23 mm
  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
CATH AFAPRO28 AFA PRO 28MM US PB
MEDTRONIC, INC.
AFAPRO28
Not in Commercial Distribution

  • 00763000088637 ()

  • Catheter shaft size 10.5 Fr
  • Catheter tip width 28 mm
  • Length: 95.0 Centimeter


  • Cardiac cryosurgical system catheter
The Tube consists of BioFilmChip Microarray made of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-5560-01
In Commercial Distribution

  • 10850009370232 ()
03-5560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
GORE SEPTAL OCCLUDER 15MM ASD
W. L. Gore & Associates, Inc.
GSXA0015
Not in Commercial Distribution

  • 00733132617609 ()

  • Catheter Gauge: 10 French
  • Outer Diameter: 15 Millimeter
GSXA0015

  • Cardiac defect occluder
Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-001
In Commercial Distribution

  • 05060116920659 ()
  • 05060116920642 ()
  • 05060116920635 ()


  • Manual-afterloading brachytherapy system source delivery procedure kit
Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
BIOCOMPATIBLES UK LTD
990226.SPE
In Commercial Distribution

  • 05060116920253 ()
  • 05060116920260 ()
  • 05060116920277 ()


  • Manual brachytherapy source, permanent implant
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