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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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Kosmo Femoral Hip System - 00843575110596

High Offset Collared Hip Stem Size 9
B-ONE ORTHO, CORP.
8810101170
In Commercial Distribution

  • 00843575110596 ()
8810101170

  • Press-fit femoral stem prosthesis

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

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 - 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

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 - 00609271230927

Women's 9 / Men's 7.5 Black Wide width
DARCO INTERNATIONAL, INC.
GS090WB
In Commercial Distribution

  • 20609271230921 ()
  • 00609271230927 ()
GS090WB

  • 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

OsteoMed - 00845694026475

MFx Angulated Locking Curved Plate, 9 Hole
OSTEOMED LLC
214-2007
In Commercial Distribution

  • 00845694026475 ()

  • Length: 47 Millimeter
214-2007

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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