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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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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
OsteoSurge300 Putty, 10cc - 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.
56500100
In Commercial Distribution

  • M386565001001 ()
  • 10889981055851 ()

  • 10cc
56500100

  • Bone matrix implant, human-derived
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
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
OsteoSurge100, 10cc - 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.
56300100
In Commercial Distribution

  • M386563001001 ()
  • 10889981055820 ()

  • 10cc
56300100

  • Bone matrix implant, human-derived
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
OsteoSurge100, 2.5cc - 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.
56300025
In Commercial Distribution

  • M386563000251 ()
  • 10889981055806 ()

  • 2.5cc
56300025

  • Bone matrix implant, human-derived
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, 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, 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
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