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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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TO BE ASSIGNED - 00193033445358

No Description
FGX INTERNATIONAL INC.
10259817.INT
In Commercial Distribution

  • 00193033445358 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445341

No Description
FGX INTERNATIONAL INC.
10259816.INT
In Commercial Distribution

  • 00193033445341 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445334

No Description
FGX INTERNATIONAL INC.
10259815.INT
In Commercial Distribution

  • 00193033445334 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445327

No Description
FGX INTERNATIONAL INC.
10259814.INT
In Commercial Distribution

  • 00193033445327 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445310

No Description
FGX INTERNATIONAL INC.
10259768.INT
In Commercial Distribution

  • 00193033445310 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445303

No Description
FGX INTERNATIONAL INC.
10259767.INT
In Commercial Distribution

  • 00193033445303 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445280

No Description
FGX INTERNATIONAL INC.
10259787.INT
In Commercial Distribution

  • 00193033445280 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445273

No Description
FGX INTERNATIONAL INC.
10259784.INT
In Commercial Distribution

  • 00193033445273 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445266

No Description
FGX INTERNATIONAL INC.
10259777.INT
In Commercial Distribution

  • 00193033445266 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445259

No Description
FGX INTERNATIONAL INC.
10259813.INT
In Commercial Distribution

  • 00193033445259 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445242

No Description
FGX INTERNATIONAL INC.
10259793.INT
In Commercial Distribution

  • 00193033445242 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445235

No Description
FGX INTERNATIONAL INC.
10259764.INT
In Commercial Distribution

  • 00193033445235 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445228

No Description
FGX INTERNATIONAL INC.
10259760.INT
In Commercial Distribution

  • 00193033445228 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445204

No Description
FGX INTERNATIONAL INC.
10259758.INT
In Commercial Distribution

  • 00193033445204 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445297

No Description
FGX INTERNATIONAL INC.
10259788.INT
In Commercial Distribution

  • 00193033445297 ()


  • Tinted non-prescription spectacles

TO BE ASSIGNED - 00193033445211

No Description
FGX INTERNATIONAL INC.
10259759.INT
In Commercial Distribution

  • 00193033445211 ()


  • Tinted non-prescription spectacles

ENDOSKELETON® TO - 00191375004981

Odd Size Trays
TITAN SPINE, LLC
3900-1011
Not in Commercial Distribution

  • 00191375004981 ()

  • Length: 21 Inch
  • Width: 10 Inch
  • Height: 4 Inch
3900-1011

  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375004974

Perforated Tray System
TITAN SPINE, LLC
3900-1001
Not in Commercial Distribution

  • 00191375004974 ()

  • Length: 21 Inch
  • Width: 10 Inch
  • Height: 4 Inch
3900-1001

  • Instrument tray, reusable

ENDOSKELETON® TO - 00191375004967

Trial, PLIF, 15mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2215
In Commercial Distribution

  • 00191375004967 ()

  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • Height: 15 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004950

Trial, PLIF, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2214
In Commercial Distribution

  • 00191375004950 ()

  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Height: 14 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004943

Trial, PLIF, 13mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2213
In Commercial Distribution

  • 00191375004943 ()

  • width(MLxAP), 22 x 9, mm
  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • Height: 13 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004936

Trial, PLIF, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2212
In Commercial Distribution

  • 00191375004936 ()

  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Height: 12 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004929

Trial, PLIF, 11mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2211
In Commercial Distribution

  • 00191375004929 ()

  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 11 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004912

Trial, PLIF, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2210
In Commercial Distribution

  • 00191375004912 ()

  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 10 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004905

Trial, PLIF, 9mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2209
In Commercial Distribution

  • 00191375004905 ()

  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 9 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004899

Trial, PLIF, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2208
In Commercial Distribution

  • 00191375004899 ()

  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 8 Millimeter


  • Spinal implant trial

ENDOSKELETON® TO - 00191375004882

Remover Implant, Threaded
MEDTRONIC SOFAMOR DANEK, INC.
3200-4000
In Commercial Distribution

  • 00191375004882 ()

  • Length: 13 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable

ENDOSKELETON® TO - 00191375004875

Interbody Fusion Device 4 Degree Oblique 16mm
TITAN SPINE, LLC
3114-3116
Not in Commercial Distribution

  • 00191375004875 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 16 Millimeter
3114-3116

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004868

Interbody Fusion Device 4 Degree Oblique 15mm
TITAN SPINE, LLC
3114-3115
Not in Commercial Distribution

  • 00191375004868 ()

  • Width: 31 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Depth: 11 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 15 Millimeter
3114-3115

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004851

Interbody Fusion Device 4 Degree Oblique 14mm
TITAN SPINE, LLC
3114-3114
Not in Commercial Distribution

  • 00191375004851 ()

  • Lordotic Angle 4 Deg
  • Height: 14 Millimeter
  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
3114-3114

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004844

Interbody Fusion Device 4 Degree Oblique 13mm
TITAN SPINE, LLC
3114-3113
Not in Commercial Distribution

  • 00191375004844 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 13 Millimeter
3114-3113

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004837

Interbody Fusion Device 4 Degree Oblique 12mm
TITAN SPINE, LLC
3114-3112
Not in Commercial Distribution

  • 00191375004837 ()

  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Depth: 11 Millimeter
  • Height: 12 Millimeter
  • Lordotic Angle 4 Deg
3114-3112

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004820

Interbody Fusion Device 4 Degree Oblique 11mm
TITAN SPINE, LLC
3114-3111
Not in Commercial Distribution

  • 00191375004820 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter
  • Angle: 4 degree
  • Lordotic Angle 4 Deg
  • Height: 11 Millimeter
3114-3111

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004813

Interbody Fusion Device 4 Degree Oblique 10mm
TITAN SPINE, LLC
3114-3110
Not in Commercial Distribution

  • 00191375004813 ()

  • width(MLxAP), 31 x 11, mm
  • Depth: 11 Millimeter
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Height: 10 Millimeter
  • Lordotic Angle 4 Deg
3114-3110

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004806

Interbody Fusion Device 4 Degree Oblique 9mm
TITAN SPINE, LLC
3114-3109
Not in Commercial Distribution

  • 00191375004806 ()

  • Angle: 4 degree
  • Width: 31 Millimeter
  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Height: 9 Millimeter
  • Lordotic Angle 4 Deg
3114-3109

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004790

Interbody Fusion Device 4 Degree Oblique 8mm
TITAN SPINE, LLC
3114-3108
Not in Commercial Distribution

  • 00191375004790 ()

  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter
  • Depth: 11 Millimeter
  • Angle: 4 degree
  • Height: 8 Millimeter
  • Lordotic Angle 4 Deg
3114-3108

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004783

Interbody Fusion Device 4 Degree PLIF 16mm
TITAN SPINE, LLC
3114-2616
Not in Commercial Distribution

  • 00191375004783 ()

  • width(MLxAP), 26 x 9, mm
  • Angle: 4 degree
  • Width: 26 Millimeter
  • Depth: 9 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 16 Millimeter
3114-2616

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004776

Interbody Fusion Device 4 Degree PLIF 15mm
MEDTRONIC SOFAMOR DANEK, INC.
3114-2615
In Commercial Distribution

  • 00191375004776 ()

  • Depth: 9 Millimeter
  • Angle: 4 degree
  • width(MLxAP), 26 x 9, mm
  • Width: 26 Millimeter
  • Height: 15 Millimeter
  • Lordotic Angle 4 Deg


  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004769

Interbody Fusion Device 4 Degree PLIF 14mm
MEDTRONIC SOFAMOR DANEK, INC.
3114-2614
In Commercial Distribution

  • 00191375004769 ()

  • width(MLxAP), 26 x 9, mm
  • Depth: 9 Millimeter
  • Angle: 4 degree
  • Width: 26 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage

ENDOSKELETON® TO - 00191375004752

Interbody Fusion Device 4 Degree PLIF 13mm
MEDTRONIC SOFAMOR DANEK, INC.
3114-2613
In Commercial Distribution

  • 00191375004752 ()

  • Width: 26 Millimeter
  • Angle: 4 degree
  • width(MLxAP), 26 x 9, mm
  • Depth: 9 Millimeter
  • Height: 13 Millimeter
  • Lordotic Angle 4 Deg


  • Metallic spinal interbody fusion cage
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