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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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MOBIO™ Total Knee System - 00843575105059

PS Femur, Size 9, RIGHT, STANDARD, Cemented
B-ONE ORTHO, CORP.
8821131092
In Commercial Distribution

  • 00843575105059 ()
8821131092

  • Posterior-stabilized total knee prosthesis

MOBIO™ Total Knee System - 00843575105042

PS Femur, Size 9, LEFT, STANDARD, Cemented
B-ONE ORTHO, CORP.
8821131091
In Commercial Distribution

  • 00843575105042 ()
8821131091

  • Posterior-stabilized total knee prosthesis

EIT PLIF Trial - 04260557836262

Trial, H: 9 mm, 0°, 30/11
EIT Emerging Implant Technologies GmbH
PET00930
In Commercial Distribution

  • 04260557836262 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836231

Trial, H: 16 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01610
In Commercial Distribution

  • 04260557836231 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836224

Trial, H: 15 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01510
In Commercial Distribution

  • 04260557836224 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836217

Trial, H: 14 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01410
In Commercial Distribution

  • 04260557836217 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836200

Trial, H: 13 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01310
In Commercial Distribution

  • 04260557836200 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836194

Trial, H: 12 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01210
In Commercial Distribution

  • 04260557836194 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836187

Trial, H: 11 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01110
In Commercial Distribution

  • 04260557836187 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836170

Trial, H: 10 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET01010
In Commercial Distribution

  • 04260557836170 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836156

Trial, H: 8 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET00810
In Commercial Distribution

  • 04260557836156 ()


  • Spinal implant trial

EIT PLIF Trial - 04260557836149

Trial, H: 7 mm, 0°, 30/9
EIT Emerging Implant Technologies GmbH
PET00710
In Commercial Distribution

  • 04260557836149 ()


  • Spinal implant trial

Novel - 00844856030695

Novel TL, Large Trial, Non-Lordotic, 9 mm
ALPHATEC SPINE, INC.
64637-009
In Commercial Distribution

  • 00844856030695 ()

  • Width: 10 Millimeter
  • Length: 30 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00844856030619

Novel TL, Medium Trial, Non-Lordotic, 9 mm
ALPHATEC SPINE, INC.
64636-009
In Commercial Distribution

  • 00844856030619 ()

  • Height: 9 Millimeter
  • Length: 28 Millimeter
  • Width: 10 Millimeter


  • Spinal implant trial

Novel - 00844856030534

Novel TL, Small Trial, Non-Lordotic, 9 mm
ALPHATEC SPINE, INC.
64635-009
In Commercial Distribution

  • 00844856030534 ()

  • Length: 24 Millimeter
  • Width: 10 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

DARCO® GentleStep™ Shoe - 00609271231085

Women's 10.5 / Men's 9 Black Extra-wide width
DARCO INTERNATIONAL, INC.
GS105XB
In Commercial Distribution

  • 20609271231089 ()
  • 00609271231085 ()
GS105XB

  • Orthotic shoe, non-customized

DARCO® GentleStep™ Shoe - 00609271231078

Women's 10.5 / Men's 9 Black Wide width
DARCO INTERNATIONAL, INC.
GS105WB
In Commercial Distribution

  • 20609271231072 ()
  • 00609271231078 ()
GS105WB

  • Orthotic shoe, non-customized

DARCO® GentleStep™ Shoe - 00609271230934

Women's 9 / Men's 7.5 Black Extra-wide width
DARCO INTERNATIONAL, INC.
GS090XB
In Commercial Distribution

  • 20609271230938 ()
  • 00609271230934 ()
GS090XB

  • Orthotic shoe, non-customized

DARCO® GentleStep™ Shoe - 00609271230910

Women's 9 / Men's 7.5 Black Medium width
DARCO INTERNATIONAL, INC.
GS090MB
In Commercial Distribution

  • 20609271230914 ()
  • 00609271230910 ()
GS090MB

  • Orthotic shoe, non-customized

DARCO® GentleStep™ Shoe - 00609271231061

Women's 10.5 / Men's 9 Black Medium width
DARCO INTERNATIONAL, INC.
GS105MB
In Commercial Distribution

  • 20609271231065 ()
  • 00609271231061 ()
GS105MB

  • Orthotic shoe, non-customized
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