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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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Optium DBM Gel, 3 cc
LIFENET HEALTH
TGEL03
In Commercial Distribution

  • 00889858625708 ()

  • 3 cc
TGEL03

  • Bone matrix implant, human-derived
Sterile Cann CC Shank, Ø8.5x40mm
NEXXT SPINE, LLC
20-SCC-8540-SP
In Commercial Distribution

  • 00889929048146 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 40 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø7.5x25mm
NEXXT SPINE, LLC
20-SCC-7525-SP
In Commercial Distribution

  • 00889929048139 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø7.0x25mm
NEXXT SPINE, LLC
20-SCC-7025-SP
In Commercial Distribution

  • 00889929048122 ()

  • Outer Diameter: 7.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø6.5x25mm
NEXXT SPINE, LLC
20-SCC-6525-SP
In Commercial Distribution

  • 00889929048115 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø6.0x25mm
NEXXT SPINE, LLC
20-SCC-6025-SP
In Commercial Distribution

  • 00889929048108 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø5.5x25mm
NEXXT SPINE, LLC
20-SCC-5525-SP
In Commercial Distribution

  • 00889929048092 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Sterile Cann CC Shank, Ø5.0x25mm
NEXXT SPINE, LLC
20-SCC-5025-SP
In Commercial Distribution

  • 00889929048085 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
FILES HED CC 25MM #8
DARBY DENTAL SUPPLY, LLC
9512440
In Commercial Distribution

  • 00889813040911 ()
  • 00889813040928 ()
9512440

  • Manual endodontic file/rasp, single-use
FILES HED CC 21MM #8
DARBY DENTAL SUPPLY, LLC
9512417
In Commercial Distribution

  • 00889813040898 ()
  • 00889813040904 ()
9512417

  • Manual endodontic file/rasp, single-use
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