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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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5° x 60mm Left TMT Plate
Leith Medical LLC
0200-0260
In Commercial Distribution

  • B953020002600 ()

  • Angle: 5 degree
  • Length: 60 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
5° x 45mm Left TMT Plate
Leith Medical LLC
0200-0245
In Commercial Distribution

  • B953020002450 ()

  • Angle: 5 degree
  • Length: 45 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
5° x 60mm Straight TMT Plate
Leith Medical LLC
0200-0160
In Commercial Distribution

  • B953020001600 ()

  • Angle: 5 degree
  • Length: 60 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
5° x 45mm Straight TMT Plate
Leith Medical LLC
0200-0145
In Commercial Distribution

  • B953020001450 ()

  • Angle: 5 degree
  • Length: 45 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
EMPOWR Knee, Revision Femur, 5 Right
Encore Medical, L.P.
245-02-105
In Commercial Distribution

  • 00190446681076 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
EMPOWR Knee, Revision Femur, 5 Left
Encore Medical, L.P.
245-01-105
In Commercial Distribution

  • 00190446680970 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTABLE, UE DISPOSABLE KIT, 5 PACK
DJO, LLC
804-33-105
In Commercial Distribution

  • 00190446667407 ()


  • Arm procedure positioner, reusable
CALIBRATE NanoTec CCX S, 7x12x22mm 5°
ALPHATEC SPINE, INC.
326-PRO-07122205-S
In Commercial Distribution

  • 00190376605142 ()

  • Width: 12 Millimeter
  • Height: 7 Millimeter
  • Length: 22 Millimeter
  • Angle: 5 degree


  • Metallic spinal interbody fusion cage
CALIBRATE NanoTec CCX S, 7x10x30mm 5°
ALPHATEC SPINE, INC.
326-PRO-07103005-S
In Commercial Distribution

  • 00190376605104 ()

  • Height: 7 Millimeter
  • Length: 30 Millimeter
  • Angle: 5 degree
  • Width: 10 Millimeter


  • Metallic spinal interbody fusion cage
CALIBRATE NanoTec CCX S, 7x10x26mm 5°
ALPHATEC SPINE, INC.
326-PRO-07102605-S
In Commercial Distribution

  • 00190376605067 ()

  • Height: 7 Millimeter
  • Angle: 5 degree
  • Width: 10 Millimeter
  • Length: 26 Millimeter


  • Metallic spinal interbody fusion cage
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