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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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BIDIR CATH LG CURVE CEDTB400L US
MEDTRONIC, INC.
CEDTB400L
In Commercial Distribution

  • 00763000536671 ()

  • Catheter tip size 2.50mm (7.5Fr)
  • Catheter Length: 110.0 Centimeter
  • Electrode spacing between distal ring electrode and proximal ring electrode 2mm
  • Ring electrode length 1.3mm
  • Distal electrode length .6mm
  • Outer Diameter: 2.67 Millimeter
  • Composite tip electrode length 4.1mm
  • Tip Bend Radius: 63.0 Millimeter
  • Electrode spacing between composite electrode and distal ring electrode 3.5mm
  • Electrode spacing between distal electrode and proximal electrode .5mm


  • Cardiac radio-frequency ablation system catheter
FOOTSWITCH CEDTFS100 DIAMONDTEMP US
MEDTRONIC, INC.
CEDTFS100
In Commercial Distribution

  • 00763000512255 ()


  • Foot-switch, electrical
KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS
MEDTRONIC, INC.
20MRK
In Commercial Distribution

  • 00763000279783 ()


  • Catheter/overtube balloon inflator, single-use
KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ
MEDTRONIC, INC.
20MRK
In Commercial Distribution

  • 00763000228699 ()


  • Catheter/overtube balloon inflator, single-use
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 Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1137
In Commercial Distribution

  • 00853095008426 ()

  • Balloon Diameter: 30 Millimeter
  • Catheter Length: 30 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1137-30030

  • Urethral dilatation catheter, non-medicated
Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System
BEST VASCULAR, INC.
BRX-0346
In Commercial Distribution

  • M097BRX03460 ()
BRX-0346

  • Coronary artery brachytherapy system applicator, manual-afterloading
Accessory kit For use with the Model 3120 Programmer Recorder Monitor PRM
BOSTON SCIENTIFIC CORPORATION
3130
In Commercial Distribution

  • 00802526536007 ()


  • Cardiac pulse generator programmer
Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution

  • 00812394021505 ()
40-00296-05

  • External defibrillator application software
Charger kit, English, for rechargeable battery: Powerheart AED G3 Pro model 9300P
Zoll Medical Corporation
9044-001
In Commercial Distribution

9044-001

  • Non-rechargeable public semi-automated external defibrillator
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