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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Facet Fixx, Screw, Partial Thread, Ø4.5 x 35mm
NEXXT SPINE, LLC
14-10-4535
In Commercial Distribution

  • 00889929000724 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Partial Thread, Ø4.5 x 32.5mm
NEXXT SPINE, LLC
14-10-4533
In Commercial Distribution

  • 00889929000717 ()

  • Length: 32.5 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Partial Thread, Ø4.5 x 30mm
NEXXT SPINE, LLC
14-10-4530
In Commercial Distribution

  • 00889929000700 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Partial Thread, Ø4.5 x 27.5mm
NEXXT SPINE, LLC
14-10-4528
In Commercial Distribution

  • 00889929000694 ()

  • Length: 27.5 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Partial Thread, Ø4.5 x 25mm
NEXXT SPINE, LLC
14-10-4525
In Commercial Distribution

  • 00889929000687 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Facet Fixx, Screw, Partial Thread, Ø4.5 x 20mm
NEXXT SPINE, LLC
14-10-4520
In Commercial Distribution

  • 00889929000670 ()

  • Length: 20 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Nephro-EZDilate 30FR (10mm) X 15cm NEPHROSTOMY BALLOON CATHETER
Gyrus ACMI, LLC
BPCN1015
In Commercial Distribution

  • 00821925033023 ()


  • Nephrostomy catheter
Nephro-EZDilate 24FR (8mm) x 15cm NEPHROSTOMY BALLOON CATHETER
Gyrus ACMI, LLC
BPCN0815
In Commercial Distribution

  • 00821925033009 ()


  • Nephrostomy catheter
HEMOSTAT GAUZE 0.5" X 0.5" STERILE 4 PLY
AMD Medicom Inc
AHMDG20
Not in Commercial Distribution

  • 20686864048927 ()
  • 10686864048920 ()
  • 00686864048923 ()

  • 0.5 x 0.5 Inch
AHMDG20

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
HEMOSTAT GAUZE 2" X 2" STERILE 4 PLY
AMD Medicom Inc
AHM0022
Not in Commercial Distribution

  • 10686864919879 ()
  • 10686864909863 ()
  • 20686864909860 ()

  • 2 x 2 Inch
AHM0022

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
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