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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Total Talus, No Suture Hole, 100%
Restor3d, Inc.
1102-03
In Commercial Distribution

  • 00840097509761 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 95%
Restor3d, Inc.
1102-02
In Commercial Distribution

  • 00840097509754 ()


  • Custom-made hand/foot bone prosthesis
Total Talus, No Suture Hole, 90%
Restor3d, Inc.
1102-01
In Commercial Distribution

  • 00840097509747 ()


  • Custom-made hand/foot bone prosthesis
105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug
AUTO LOCK TOURNIQUET
SONTEC INSTRUMENTS, INC.
1100-782
Not in Commercial Distribution

  • 00192896090682 ()
1100-782

  • Limb tourniquet, manual, reusable
No Description
Thoratec Switzerland GmbH
104318
In Commercial Distribution

  • 07640135140603 ()
104318

  • External ventricular circulatory assist system
No Description
Biotronik AG
5.0/26/140
In Commercial Distribution

  • 07640130447318 ()

  • Length: 26 mm
  • Usable Length: 140 cm
  • Diameter: 5 mm
434903

  • Bare-metal coronary artery stent
No Description
Biotronik AG
4.5/26/140
In Commercial Distribution

  • 07640130447301 ()

  • Diameter: 4.5 mm
  • Usable Length: 140 cm
  • Length: 26 mm
434902

  • Bare-metal coronary artery stent
No Description
Biotronik AG
4.0/26/140
In Commercial Distribution

  • 07640130447295 ()

  • Usable Length: 140 cm
  • Length: 26 mm
  • Diameter: 4 mm
434901

  • Bare-metal coronary artery stent
No Description
Biotronik AG
3.5/26/140
In Commercial Distribution

  • 07640130447288 ()

  • Length: 26 mm
  • Diameter: 3.5 mm
  • Usable Length: 140 cm
434900

  • Bare-metal coronary artery stent
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