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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 300C Putty - 10889981055882

OsteoSurge300c Putty, 10cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. OsteoSurge300c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56510100
In Commercial Distribution

  • M386565101001 ()
  • 10889981055882 ()

  • 10cc
56510100

  • Bone matrix implant, human-derived

OsteoSurge 300C Putty - 10889981055868

OsteoSurge300c Putty, 2.5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. OsteoSurge300c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56510025
In Commercial Distribution

  • M386565100251 ()
  • 10889981055868 ()

  • 2.5cc
56510025

  • Bone matrix implant, human-derived

OsteoSurge 300 Putty - 10889981055844

OsteoSurge300 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500050
In Commercial Distribution

  • M386565000501 ()
  • 10889981055844 ()

  • 5cc
56500050

  • Bone matrix implant, human-derived

OsteoSurge 300 Putty - 10889981055837

OsteoSurge300 Putty, 2.5cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500025
In Commercial Distribution

  • M386565000251 ()
  • 10889981055837 ()

  • 2.5cc
56500025

  • Bone matrix implant, human-derived

OsteoSurge 100 Putty - 10889981055813

OsteoSurge100, 5cc - 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.
56300050
In Commercial Distribution

  • M386563000501 ()
  • 10889981055813 ()

  • 5cc
56300050

  • Bone matrix implant, human-derived

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 - 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 - 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 Gel - 10889981055677

OsteoSparx Gel, 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.
56200010
In Commercial Distribution

  • M386562000101 ()
  • 10889981055677 ()

  • 1cc
56200010

  • Bone matrix implant, human-derived
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