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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, 85x11mm
ISOTIS ORTHOBIOLOGICS, INC.
56800115
In Commercial Distribution

  • 10889981149369 ()

  • 85x11mm
56800115

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

  • 10889981149345 ()

  • 45x11mm
56800060

  • 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, 45x11mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-060
In Commercial Distribution

  • 10889981149307 ()

  • 45x11mm
02-8000-060

  • Bone matrix implant, human-derived
OsteoSurge 300 Putty, 1cc -  demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500010
In Commercial Distribution

  • 10889981129729 ()

  • 1cc
56500010

  • Bone matrix implant, human-derived
Accell Evo3 Putty, 1cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
Seaspine Orthopedics Corporation
02-5000-010
In Commercial Distribution

  • 10889981129712 ()

  • 1cc
02-5000-010

  • Bone matrix implant, human-derived
OsteoBallast, 115 x11mm
Seaspine Orthopedics Corporation
56800160
In Commercial Distribution

  • 10889981189266 ()
56800160

  • Bone matrix implant, human-derived
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