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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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DynaGraft II Gel, 0.5cc - 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.
02-2000-005
In Commercial Distribution

  • M3860220000051 ()
  • 10889981055509 ()

  • 0.5cc
02-2000-005

  • Bone matrix implant, human-derived
Accell Connexus, 10cc - 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.
02-3000-100
In Commercial Distribution

  • M3860230001001 ()
  • 10889981055493 ()

  • 10cc
02-3000-100

  • Bone matrix implant, human-derived
Accell Connexus, 5cc - 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.
02-3000-050
In Commercial Distribution

  • M3860230000501 ()
  • 10889981055486 ()

  • 5cc
02-3000-050

  • Bone matrix implant, human-derived
Accell Connexus, 0.5cc - 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.
02-3000-005
In Commercial Distribution

  • M3860230000051 ()
  • 10889981055455 ()

  • 0.5cc
02-3000-005

  • 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,5 cc - 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.
02-5000-050
In Commercial Distribution

  • M3860250000501 ()
  • 10889981055400 ()

  • 5cc
02-5000-050

  • Bone matrix implant, human-derived
Accell Evo3 Putty, 2.5cc - 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.
02-5000-025
In Commercial Distribution

  • M3860250000251 ()
  • 10889981055394 ()

  • 2.5cc
02-5000-025

  • 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, 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
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