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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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Biomaterials
KEYSTONE DENTAL, INC.
10.110.1050
In Commercial Distribution

  • D7681011010500 ()

  • .5cc - 5cc
10.110.1050

  • Dental bone matrix implant, human-derived
No Description
Levo Medical Corporation
Manager
In Commercial Distribution

61689

  • Tinnitus masking application software
No Description
Levo Medical Corporation
Patient
In Commercial Distribution

60452

  • Tinnitus masking application software
MAR0Fuse Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse5cc
Not in Commercial Distribution

  • M896MAR0FUSE5CC1 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, human-derived
MAR0Fuse Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse1cc
Not in Commercial Distribution

  • M896MAR0FUSE1CC1 ()

  • Total Volume: 1 Milliliter


  • Bone matrix implant, human-derived
MAR0FUSE Demineralized Bone Matrix Gel
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse10cc
Not in Commercial Distribution

  • M896MAR0FUSE10CC1 ()

  • Total Volume: 10 Milliliter


  • 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
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
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