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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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OsteoSurge 100 Putty - 10889981055790

OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300010
In Commercial Distribution

  • M386563000101 ()
  • 10889981055790 ()

  • 1cc
56300010

  • 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 - 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 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 - 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 - 10889981055660

Accell TBM, 7 cm diameter - 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.
02-4000-760
In Commercial Distribution

  • M3860240007601 ()
  • 10889981055660 ()

  • 7cm Round
02-4000-760

  • 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 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 - 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
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