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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 C Putty - 10889981055783

OsteoSparx C 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.
56230100
In Commercial Distribution

  • M386562301001 ()
  • 10889981055783 ()

  • 10cc
56230100

  • Bone matrix implant, human-derived

OsteoSparx C Putty - 10889981055776

OsteoSparx C 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.
56230050
In Commercial Distribution

  • M386562300501 ()
  • 10889981055776 ()

  • 5cc
56230050

  • Bone matrix implant, human-derived

OsteoSparx C Paste - 10889981055769

OsteoSparx C 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.
56220080
In Commercial Distribution

  • M386562200801 ()
  • 10889981055769 ()

  • 8cc
56220080

  • Bone matrix implant, human-derived

OsteoSparx C Paste - 10889981055752

OsteoSparx C 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.
56220030
In Commercial Distribution

  • M386562200301 ()
  • 10889981055752 ()

  • 3cc
56220030

  • Bone matrix implant, human-derived

OsteoSparx C Paste - 10889981055745

OsteoSparx C 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.
56220010
In Commercial Distribution

  • M386562200101 ()
  • 10889981055745 ()

  • 1cc
56220010

  • Bone matrix implant, human-derived

OsteoSparx Putty - 10889981055738

OsteoSparx 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.
56210100
In Commercial Distribution

  • M386562101001 ()
  • 10889981055738 ()

  • 10cc
56210100

  • Bone matrix implant, human-derived

OsteoSparx Putty - 10889981055721

OsteoSparx 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.
56210050
In Commercial Distribution

  • M386562100501 ()
  • 10889981055721 ()

  • 5cc
56210050

  • Bone matrix implant, human-derived

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 - 10889981055691

OsteoSparx Gel, 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.
56200100
In Commercial Distribution

  • M386562001001 ()
  • 10889981055691 ()

  • 10cc
56200100

  • Bone matrix implant, human-derived
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