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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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8mm H x 24mm W x 25mm L x 8 degree Lateral Implant
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587XL08242580 ()

  • Width: 24 Millimeter
  • Length: 25 Millimeter
  • Height: 8 Millimeter
  • Angle: 8 degree
XL082425-8

  • Polymeric spinal interbody fusion cage
8mm H x 24mm W x 25mm L x 12 degree Lateral Implant
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587XL082425120 ()

  • Width: 24 Millimeter
  • Length: 25 Millimeter
  • Height: 8 Millimeter
  • Angle: 12 degree
XL082425-12

  • Polymeric spinal interbody fusion cage
MRO2, Up to Five Stations Portable RO, 2,200 GPD, 115V
AMERIWATER, LLC
MRO2
In Commercial Distribution

  • 00817927020215 ()

  • Weight: 234 Pound
  • Height: 52 Inch
  • Width: 18.5 Inch
  • Depth: 24 Inch


  • Reverse-osmosis water purification system
MROS, Single Patient Portable RO, 730 GPD, 115V
AMERIWATER, LLC
MROS
In Commercial Distribution

  • 00817927020000 ()

  • Weight: 135 Pound
  • Depth: 24 Inch
  • Width: 17 Inch
  • Height: 47 Inch


  • Reverse-osmosis water purification system
MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V
AMERIWATER, LLC
MRO1
In Commercial Distribution

  • 00817927020017 ()

  • Weight: 205 Pound
  • Depth: 24 Inch
  • Width: 18.5 Inch
  • Height: 52 Inch


  • Reverse-osmosis water purification system
14mm H x 28mm W x 24mm L x 8 Degree ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A14282480 ()

  • Angle: 8 degree
  • Length: 24 Millimeter
  • Width: 28 Millimeter
  • Height: 14 Millimeter
A142824-8

  • Polymeric spinal interbody fusion cage
14mm H x 28mm W x 24mm L x 12 degree ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A142824120 ()

  • Width: 28 Millimeter
  • Length: 24 Millimeter
  • Height: 14 Millimeter
  • Angle: 12 degree
A142824-12

  • Polymeric spinal interbody fusion cage
12mm H x 42mm W x 24mm L x 8 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A12422480 ()

  • Width: 42 Millimeter
  • Length: 24 Millimeter
  • Height: 12 Millimeter
  • Angle: 8 degree
A124224-8

  • Polymeric spinal interbody fusion cage
12mm H x 42mm W x 24mm L x 12 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A124224120 ()

  • Width: 42 Millimeter
  • Length: 24 Millimeter
  • Height: 12 Millimeter
  • Angle: 12 degree
A124224-12

  • Polymeric spinal interbody fusion cage
12mm H x 36mm W x 24mm L x 15 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A123624150 ()

  • Width: 36 Millimeter
  • Length: 24 Millimeter
  • Height: 12 Millimeter
  • Angle: 15 degree
A123624-15

  • Polymeric spinal interbody fusion cage
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