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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, 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, 2.5cc - 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.
02-3000-025
In Commercial Distribution

  • M3860230000251 ()
  • 10889981055479 ()

  • 2.5cc
02-3000-025

  • 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, 2.5cc - 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.
02-6000-025
In Commercial Distribution

  • M3860260000251 ()
  • 10889981055424 ()

  • 2.5cc
02-6000-025

  • 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
DBM T45005INT 5CC PASTE GRAFTON PLUS
MEDTRONIC SOFAMOR DANEK, INC.
T45005INT
In Commercial Distribution

  • 00643169965102 ()


  • Bone matrix implant, human-derived
DBM T45001INT 1CC PASTE GRAFTON PLUS
MEDTRONIC SOFAMOR DANEK, INC.
T45001INT
In Commercial Distribution

  • 00643169965096 ()

  • 1CC


  • Bone matrix implant, human-derived
DBM T44150INT 10CC GRAFTON ORTHOBLEND SM
MEDTRONIC SOFAMOR DANEK, INC.
T44150INT
In Commercial Distribution

  • 00643169965089 ()


  • Bone matrix implant, human-derived
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