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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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Orthoblast II Putty - 10889981055622

OrthoBlast II Putty, 5cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2110-050
In Commercial Distribution

  • M3860221100501 ()
  • 10889981055622 ()

  • 5cc
02-2110-050

  • Bone matrix implant, human-derived

Orthoblast II Paste - 10889981055608

OrthoBlast II Paste, 3cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2100-030
In Commercial Distribution

  • M3860221000301 ()
  • 10889981055608 ()

  • 3cc
02-2100-030

  • Bone matrix implant, human-derived

Dynagraft II Putty - 10889981055578

DynaGraft II Putty, 10cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2010-100
In Commercial Distribution

  • M3860220101001 ()
  • 10889981055578 ()

  • 10cc
02-2010-100

  • Bone matrix implant, human-derived

Dynagraft II Putty - 10889981055547

DynaGraft II Putty, 1cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2010-010
In Commercial Distribution

  • M3860220100101 ()
  • 10889981055547 ()

  • 1cc
02-2010-010

  • Bone matrix implant, human-derived

Dynagraft II Gel - 10889981055523

DynaGraft II Gel, 5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2000-050
In Commercial Distribution

  • M3860220000501 ()
  • 10889981055523 ()

  • 5cc
02-2000-050

  • Bone matrix implant, human-derived

Dynagraft II Gel - 10889981055509

DynaGraft II Gel, 0.5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2000-005
In Commercial Distribution

  • M3860220000051 ()
  • 10889981055509 ()

  • 0.5cc
02-2000-005

  • Bone matrix implant, human-derived

Accell Connexus - 10889981055493

Accell Connexus, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-100
In Commercial Distribution

  • M3860230001001 ()
  • 10889981055493 ()

  • 10cc
02-3000-100

  • Bone matrix implant, human-derived

Accell Connexus - 10889981055486

Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-050
In Commercial Distribution

  • M3860230000501 ()
  • 10889981055486 ()

  • 5cc
02-3000-050

  • Bone matrix implant, human-derived

Accell Connexus - 10889981055455

Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-005
In Commercial Distribution

  • M3860230000051 ()
  • 10889981055455 ()

  • 0.5cc
02-3000-005

  • Bone matrix implant, human-derived

Accell Evo3 C Putty - 10889981055431

Accell Evo3c Putty, 5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-6000-050
In Commercial Distribution

  • M3860260000501 ()
  • 10889981055431 ()

  • 5cc
02-6000-050

  • Bone matrix implant, human-derived
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