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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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ALIF Sizing Trial 20mm H x 32mm W x 24mm L x 12 degrees
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587TA203224120 ()

  • Width: 32 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 12 degree
TA203224-12

  • Spinal implant trial
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
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
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
20mm H x 32mm W x 24mm L x 8 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A20322480 ()

  • Width: 32 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 8 degree
A203224-8

  • Polymeric spinal interbody fusion cage
20mm H x 32mm W x 24mm L x 15 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A203224150 ()

  • Width: 32 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 15 degree
A203224-15

  • Polymeric spinal interbody fusion cage
20mm H x 32mm W x 24mm L x 12 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A203224120 ()

  • Width: 32 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 12 degree
A203224-12

  • Polymeric spinal interbody fusion cage
20mm H x 30mm W x 24mm L x 8 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A20302480 ()

  • Width: 30 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 8 degree
A203024-8

  • Polymeric spinal interbody fusion cage
20mm H x 30mm W x 24mm L x 15 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A203024150 ()

  • Width: 30 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 15 degree
A203024-15

  • Polymeric spinal interbody fusion cage
20mm H x 30mm W x 24mm L x 12 degrees ALIF
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587A203024120 ()

  • Width: 30 Millimeter
  • Length: 24 Millimeter
  • Height: 20 Millimeter
  • Angle: 12 degree
A203024-12

  • Polymeric spinal interbody fusion cage
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