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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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OsteoSparx Putty - 10889981055714

OsteoSparx Putty, 2.5cc - 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.
56210025
In Commercial Distribution

  • M386562100251 ()
  • 10889981055714 ()

  • 2.5cc
56210025

  • Bone matrix implant, human-derived

OsteoSparx Putty - 10889981055707

OsteoSparx 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.
56210010
In Commercial Distribution

  • M386562100101 ()
  • 10889981055707 ()

  • 1cc
56210010

  • Bone matrix implant, human-derived

OsteoSparx Gel - 10889981055684

OsteoSparx 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.
56200050
In Commercial Distribution

  • M386562000501 ()
  • 10889981055684 ()

  • 5cc
56200050

  • Bone matrix implant, human-derived

Accell TBM - 10889981055653

Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-550
In Commercial Distribution

  • M3860240005501 ()
  • 10889981055653 ()

  • 5cmx5cm
02-4000-550

  • Bone matrix implant, human-derived

Orthoblast II Putty - 10889981055639

OrthoBlast II Putty, 10cc - 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.
02-2110-100
In Commercial Distribution

  • M3860221101001 ()
  • 10889981055639 ()

  • 10cc
02-2110-100

  • Bone matrix implant, human-derived

Orthoblast II Paste - 10889981055615

OrthoBlast II Paste, 8cc - 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.
02-2100-080
In Commercial Distribution

  • M3860221000801 ()
  • 10889981055615 ()

  • 8cc
02-2100-080

  • Bone matrix implant, human-derived

Orthoblast II Paste - 10889981055592

OrthoBlast II Paste, 1cc - 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.
02-2100-010
In Commercial Distribution

  • M3860221000101 ()
  • 10889981055592 ()

  • 1cc
02-2100-010

  • Bone matrix implant, human-derived

Orthoblast II Paste - 10889981055585

OrthoBlast II Paste, 0.5cc - 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.
02-2100-005
In Commercial Distribution

  • M3860221000051 ()
  • 10889981055585 ()

  • 0.5cc
02-2100-005

  • Bone matrix implant, human-derived

Dynagraft II Putty - 10889981055561

DynaGraft II Putty, 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.
02-2010-050
In Commercial Distribution

  • M3860220100501 ()
  • 10889981055561 ()

  • 5cc
02-2010-050

  • Bone matrix implant, human-derived

Dynagraft II Putty - 10889981055554

DynaGraft II Putty, 2.5cc - 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.
02-2010-025
In Commercial Distribution

  • M3860220100251 ()
  • 10889981055554 ()

  • 2.5cc
02-2010-025

  • Bone matrix implant, human-derived
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