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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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AlloSync DBM Gel, 10cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2013-10
In Commercial Distribution

  • 10889981153601 ()

  • 10cc
ABS-2013-10

  • Bone matrix implant, human-derived
AlloSync DBM Gel, 5cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2013-05
In Commercial Distribution

  • 10889981153595 ()

  • 5cc
ABS-2013-05

  • Bone matrix implant, human-derived
AlloSync DBM Gel, 1cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2013-01
In Commercial Distribution

  • 10889981153588 ()

  • 1cc
ABS-2013-01

  • Bone matrix implant, human-derived
OsteoBallast, 85x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
56800180
In Commercial Distribution

  • 10889981149376 ()

  • 85x17.5mm
56800180

  • Bone matrix implant, human-derived
OsteoBallast, 85x11mm
ISOTIS ORTHOBIOLOGICS, INC.
56800115
In Commercial Distribution

  • 10889981149369 ()

  • 85x11mm
56800115

  • Bone matrix implant, human-derived
OsteoBallast, 45x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
56800095
In Commercial Distribution

  • 10889981149352 ()

  • 45x17.5mm
56800095

  • Bone matrix implant, human-derived
OsteoBallast, 45x11mm
ISOTIS ORTHOBIOLOGICS, INC.
56800060
In Commercial Distribution

  • 10889981149345 ()

  • 45x11mm
56800060

  • Bone matrix implant, human-derived
Ballast, 85x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-180
In Commercial Distribution

  • 10889981149338 ()

  • 85x17.5mm
02-8000-180

  • Bone matrix implant, human-derived
Ballast, 85x11mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-115
In Commercial Distribution

  • 10889981149321 ()

  • 85x11mm
02-8000-115

  • Bone matrix implant, human-derived
Ballast, 45x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-095
In Commercial Distribution

  • 10889981149314 ()

  • 45x17.5mm
02-8000-095

  • Bone matrix implant, human-derived
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