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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, 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, 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, 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
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, 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, 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, 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
IsoTis Mozaik™ Moldable Morsels Mega, 2 X 7.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.
ISOTIS ORTHOBIOLOGICS, INC.
MSL150
In Commercial Distribution

  • M269MSL1501 ()
  • 10889981056063 ()

  • 2x7.5cc
MSL150

  • Bone matrix implant, composite
IsoTis Mozaik™ Moldable Morsels Max, 7.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.
ISOTIS ORTHOBIOLOGICS, INC.
MSL075
In Commercial Distribution

  • M269MSL0751 ()
  • 10889981056056 ()

  • 7.5cc
MSL075

  • Bone matrix implant, composite
IsoTis Mozaik™ Moldable Morsels Mid, 3cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.
ISOTIS ORTHOBIOLOGICS, INC.
MSL030
In Commercial Distribution

  • M269MSL0301 ()
  • 10889981056049 ()

  • 3cc
MSL030

  • Bone matrix implant, composite
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