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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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DBM P41110 0.5CC GRAFTON GEL
MEDTRONIC SOFAMOR DANEK, INC.
P41110
Not in Commercial Distribution

  • 00613994985514 ()

  • 0.5 cc volume


  • Bone matrix implant, human-derived
DBM P41120 1CC GRAFTON GEL
MEDTRONIC SOFAMOR DANEK, INC.
P41120
Not in Commercial Distribution

  • 00613994985507 ()

  • 1 cc volume


  • Bone matrix implant, human-derived
DBM P41130 5CC GRAFTON GEL
MEDTRONIC SOFAMOR DANEK, INC.
P41130
Not in Commercial Distribution

  • 00613994985491 ()

  • 5 cc volume


  • Bone matrix implant, human-derived
DBM P41150 10CC GRAFTON GEL
MEDTRONIC SOFAMOR DANEK, INC.
P41150
Not in Commercial Distribution

  • 00613994985484 ()

  • 10 cc volume


  • Bone matrix implant, human-derived
Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
92-2001
In Commercial Distribution

  • 00880304686816 ()

  • 1 cc (Volume)
92-2001

  • Bone matrix implant, human-derived
Demineralized Bone Matrix (DBM) in a Lipid Carrier
Biomet Orthopedics, LLC
92-2002
In Commercial Distribution

  • 00880304684850 ()

  • 2 cc (Volume)
92-2002

  • Bone matrix implant, human-derived
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 340-680 cc
Sientra, Inc.
SRE-LR-340S
In Commercial Distribution

  • 00812790029945 ()

  • Volume: 340-680 cc
SRE-LR-340S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 250-500 cc
Sientra, Inc.
SRE-LR-250S
In Commercial Distribution

  • 00812790029938 ()

  • Volume: 250-500 cc
SRE-LR-250S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SRE-LR-200S
In Commercial Distribution

  • 00812790029921 ()

  • Volume: 200-400 cc
SRE-LR-200S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 160-320 cc
Sientra, Inc.
SRE-LR-160S
In Commercial Distribution

  • 00812790029914 ()

  • Volume: 160-320 cc
SRE-LR-160S

  • Skin-port tissue expander
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