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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Tibial Insert, Size 1, Left Medial, 13MM
Engage UNI LLC
1-10013-113
In Commercial Distribution

  • B6951100131130 ()


  • Unicondylar knee prosthesis
Tibial Insert, Size 1, Left Medial, 11MM
Engage UNI LLC
1-10013-111
In Commercial Distribution

  • B6951100131110 ()


  • Unicondylar knee prosthesis
Tibial Insert, Size 1, Left Medial, 10MM
Engage UNI LLC
1-10013-110
In Commercial Distribution

  • B6951100131100 ()


  • Unicondylar knee prosthesis
Tibial Insert, Size 1, Left Medial, 9MM
Engage UNI LLC
1-10013-109
In Commercial Distribution

  • B6951100131090 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Right Medial, Size 6
Engage UNI LLC
1-10012-650
In Commercial Distribution

  • B6951100126500 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Right Medial, Size 5
Engage UNI LLC
1-10012-550
In Commercial Distribution

  • B6951100125500 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Right Medial, Size 4
Engage UNI LLC
1-10012-450
In Commercial Distribution

  • B6951100124500 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Right Medial, Size 3
Engage UNI LLC
1-10012-350
In Commercial Distribution

  • B6951100123500 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Left Medial, Size 3
Engage UNI LLC
1-10012-300
In Commercial Distribution

  • B6951100123000 ()


  • Unicondylar knee prosthesis
Affinium 3D Coated Tibial Tray, Right Medial, Size 2
Engage UNI LLC
1-10012-250
In Commercial Distribution

  • B6951100122500 ()


  • Unicondylar knee prosthesis
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