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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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IsoTis Mozaik™ Strip, 5cc - a resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed throughout.
ISOTIS ORTHOBIOLOGICS, INC.
CCM10155
In Commercial Distribution

  • M386CCM101551 ()
  • 10889981055936 ()

  • 5cc
CCM10155

  • Bone matrix implant, composite
IsoTis Mozaik™ Putty, 15cc - a resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed throughout.
ISOTIS ORTHOBIOLOGICS, INC.
PTY10256
In Commercial Distribution

  • M386PTY102561 ()
  • 10889981055929 ()

  • 15cc
PTY10256

  • Bone matrix implant, composite
IsoTis Mozaik™ Putty, 10cc - a resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed throughout.
ISOTIS ORTHOBIOLOGICS, INC.
PTY10210
In Commercial Distribution

  • M386PTY102101 ()
  • 10889981055912 ()

  • 10cc
PTY10210

  • Bone matrix implant, composite
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
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,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, 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, 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
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