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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 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, 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
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
No Description
SOUNDCURE, INC.
900000
In Commercial Distribution

  • 00861259000209 ()


  • Air-conduction tinnitus masker, in-the-ear
OsteoBallast, 115 x11mm
Seaspine Orthopedics Corporation
56800160
In Commercial Distribution

  • 10889981189266 ()
56800160

  • Bone matrix implant, human-derived
Ballast, 115 x11mm
Seaspine Orthopedics Corporation
02-8000-160
In Commercial Distribution

  • 10889981189259 ()
02-8000-160

  • Bone matrix implant, human-derived
AlloSync CB DBM Putty, 10cc Vial
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2014-10
In Commercial Distribution

  • 10889981153694 ()

  • 10cc
ABS-2014-10

  • Bone matrix implant, human-derived
AlloSync CB DBM Putty, 5cc Vial
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2014-05
In Commercial Distribution

  • 10889981153687 ()

  • 5cc
ABS-2014-05

  • Bone matrix implant, human-derived
AlloSync CB DBM Paste, 8cc Syringe
ISOTIS ORTHOBIOLOGICS, INC.
ABS-2015-08
In Commercial Distribution

  • 10889981153670 ()

  • 8cc
ABS-2015-08

  • Bone matrix implant, human-derived
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