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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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WVN CATH 008719 10PK 8F SONES B HIFLO 80
MEDTRONIC, INC.
008719
Not in Commercial Distribution

  • 20613994963806 ()
  • 00613994963802 ()

  • Lumen/Inner Diameter: 1.473 Millimeter
  • Catheter Gauge: 8.0 French
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use
CATHETER 008554 WVN 7.5F SONES B 100CM
MEDTRONIC, INC.
008554
Not in Commercial Distribution

  • 20613994963783 ()
  • 00613994963789 ()

  • Catheter Gauge: 7.5 French
  • Length: 100.0 Centimeter
  • Lumen/Inner Diameter: 1.245 Millimeter


  • Angiographic catheter, single-use
CATHETER 008553 WVN 7.5F SONES B 80CM
MEDTRONIC, INC.
008553
Not in Commercial Distribution

  • 20613994963776 ()
  • 00613994963772 ()

  • Catheter Gauge: 7.5 French
  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use
WVN CATH 007548 10PK 5423S 7 100 SONESCR
MEDTRONIC, INC.
007548
Not in Commercial Distribution

  • 20613994964827 ()
  • 00613994964823 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 100.0 Centimeter
  • Catheter Gauge: 7.0 French


  • Angiographic catheter, single-use
3100A/B BELLOWS / WATER TRAP
VYAIRE MEDICAL, INC.
766897
In Commercial Distribution

  • 10190752148840 ()
766897

  • Stationary electric high-frequency ventilator
No Description
KITAZATO CORPORATION
Cryotop US(B)
In Commercial Distribution

  • 14582231462923 ()
  • 04582231462926 ()
81174

  • Assisted reproduction vitrification carrier
Lancing Device
BIOTEST MEDICAL CORPORATION
8228
In Commercial Distribution

  • 04719871820049 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-5410D
In Commercial Distribution

  • 00811403015887 ()


  • Multiple electrolyte IVD, calibrator
To provide calibration points for the Na, K & Cl electrodes for AVL 982, 983 Analyzers.
Diamond Diagnostics Inc.
AV-BP0442D
In Commercial Distribution

  • 00811403010172 ()


  • Multiple electrolyte IVD, calibrator
No.
Dreve Otoplastik GmbH
0816
In Commercial Distribution

  • E23908161 ()
0816

  • Earmould, custom-made
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