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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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24 electrodes, 7mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
RHYTHMLINK INTERNATIONAL, LLC
RLSND107-1.5
In Commercial Distribution

  • 00816312020007 ()
  • 10816312020004 ()

  • Length: 7 Millimeter


  • Subdermal needle electrode
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
RHYTHMLINK INTERNATIONAL, LLC
RLSND506-1.0
In Commercial Distribution

  • 10816312025986 ()
  • 00816312025989 ()

  • Length: 13 Millimeter


  • Subdermal needle electrode
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
RHYTHMLINK INTERNATIONAL, LLC
RLSND505-1.0
In Commercial Distribution

  • 10816312025979 ()
  • 00816312025972 ()

  • Length: 13 Millimeter


  • Subdermal needle electrode
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
RHYTHMLINK INTERNATIONAL, LLC
RLSND111-2.5C
In Commercial Distribution

  • 10816312025146 ()
  • 00816312025149 ()

  • Length: 13 Millimeter


  • Subdermal needle electrode
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector
RHYTHMLINK INTERNATIONAL, LLC
RLSND501-1.0
In Commercial Distribution

  • 10816312025962 ()
  • 00816312025965 ()

  • Length: 13 Millimeter


  • Subdermal needle electrode
TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5740-2415
Not in Commercial Distribution

  • 00814112020524 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5740-2417
Not in Commercial Distribution

  • 00814112020517 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
TRUE™ DILATATION Balloon Valvuloplasty Catheter, 24 mm x 4.5 cm,110 cm catheter
Bard Peripheral Vascular, Inc.
0244512
In Commercial Distribution

  • 00801741091018 ()

  • Balloon Length, 4.5 Centimeters
  • Balloon Diameter, 24 Millimeters
  • Shaft Length, 110 Centimeters
0244512

  • Cardiac valvuloplasty catheter
Atlas® PTA Balloon Dilatation Catheter 24 mm x 40 mm, 120 cm Catheter
Bard Peripheral Vascular, Inc.
AT120244
In Commercial Distribution

  • 00801741062766 ()

  • Balloon Length, 40 Millimeter
  • Shaft Length, 120 Centimeter
  • Balloon Diameter, 24 Millimeter
AT120244

  • Peripheral angioplasty balloon catheter, basic
Atlas® PTA Balloon Dilatation Catheter 24 mm x 20 mm, 120 cm Catheter
Bard Peripheral Vascular, Inc.
AT120242
In Commercial Distribution

  • 00801741062759 ()

  • Balloon Length, 20 Millimeter
  • Balloon Diameter, 24 Millimeter
  • Shaft Length, 120 Centimeter
AT120242

  • Peripheral angioplasty balloon catheter, basic
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