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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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Darby Dental Supply, LLC - 00889813040928

FILES HED CC 25MM #8
DARBY DENTAL SUPPLY, LLC
9512440
In Commercial Distribution

  • 00889813040911 ()
  • 00889813040928 ()
9512440

  • Manual endodontic file/rasp, single-use

Darby Dental Supply, LLC - 00889813040904

FILES HED CC 21MM #8
DARBY DENTAL SUPPLY, LLC
9512417
In Commercial Distribution

  • 00889813040898 ()
  • 00889813040904 ()
9512417

  • Manual endodontic file/rasp, single-use

Optium® - 00889858625708

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

  • 00889858625708 ()

  • 3 cc
TGEL03

  • Bone matrix implant, human-derived

I/C Graft Chamber ® - 00889858395519

IC Graft Chamber - 15 cc
LIFENET HEALTH
GDS015T
In Commercial Distribution

  • 00889858395519 ()

  • LARGE/15 cc
GDS015T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395472

IC Graft Chamber - 10 cc
LIFENET HEALTH
GDS010T
In Commercial Distribution

  • 00889858395472 ()

  • MEDIUM/10 cc
GDS010T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395434

IC Graft Chamber - 5 cc
LIFENET HEALTH
GDS005T
In Commercial Distribution

  • 00889858395434 ()

  • SMALL/5 cc
GDS005T

  • Bone graft syringe, single-use

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048146

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

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048139

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

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048122

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

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048115

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
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