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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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Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-010
In Commercial Distribution

  • M3860230000101 ()
  • 10889981055462 ()

  • 1cc
02-3000-010

  • Bone matrix implant, human-derived
Accell Evo3c Putty, 10cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-6000-100
In Commercial Distribution

  • M3860260001001 ()
  • 10889981055448 ()

  • 10cc
02-6000-100

  • Bone matrix implant, human-derived
Accell Evo3c Putty, 5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-6000-050
In Commercial Distribution

  • M3860260000501 ()
  • 10889981055431 ()

  • 5cc
02-6000-050

  • Bone matrix implant, human-derived
Accell Evo3 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
02-5000-100
In Commercial Distribution

  • M3860250001001 ()
  • 10889981055417 ()

  • 10cc
02-5000-100

  • Bone matrix implant, human-derived
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, 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.
56510050
In Commercial Distribution

  • M386565100501 ()
  • 10889981055875 ()

  • 5cc
56510050

  • 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
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, 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
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