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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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Softspan Tissue Expander - 00819409020034

Tissue Expander, Calf, Smooth Surface, Remote Port, Non-Reinforced Base, 500-600 cc
Sientra, Inc.
SRE-CC-500C
In Commercial Distribution

  • 00819409020034 ()

  • Volume: 500-600 cc
SRE-CC-500C

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020027

Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Reinforced Base, 75-188 cc
Sientra, Inc.
SRE-FO-075S
In Commercial Distribution

  • 00819409020027 ()

  • Volume: 75-188 cc
SRE-FO-075S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020010

Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Reinforced Base, 60-150 cc
Sientra, Inc.
SRE-FO-060S
In Commercial Distribution

  • 00819409020010 ()

  • Volume: 60-150 cc
SRE-FO-060S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020003

Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Non-reinforced Base, 35-89 cc
Sientra, Inc.
SRE-FO-035S
In Commercial Distribution

  • 00819409020003 ()

  • Volume: 35-89 cc
SRE-FO-035S

  • Skin-port tissue expander

DBX® - W4184428025T0473

DBX Putty 2.5cc
Musculoskeletal Transplant Foundation, Inc.
428025
In Commercial Distribution

  • W4184428025T0473 ()

  • 2.5 cc volume
428025

  • Bone matrix implant, human-derived

DBX® - W4184428010T0473

DBX Putty 1cc
Musculoskeletal Transplant Foundation, Inc.
428010
In Commercial Distribution

  • W4184428010T0473 ()

  • 1 cc volume
428010

  • Bone matrix implant, human-derived

DBX® - W4184428005T0473

DBX Putty 0.5cc
Musculoskeletal Transplant Foundation, Inc.
428005
In Commercial Distribution

  • W4184428005T0473 ()

  • 0.5 cc volume
428005

  • Bone matrix implant, human-derived

Legacy DBM - W4184420810T0473

Legacy DBM, 10CC
Musculoskeletal Transplant Foundation, Inc.
420810
In Commercial Distribution

  • W4184420810T0473 ()

  • 1.0 cc volume
420810

  • Bone matrix implant, human-derived

Legacy DBM - W4184420805T0473

Legacy DBM, 5CC
Musculoskeletal Transplant Foundation, Inc.
420805
In Commercial Distribution

  • W4184420805T0473 ()

  • 1.0 cc volume
420805

  • Bone matrix implant, human-derived

Legacy DBM - W4184420802T0473

Legacy DBM, 2.5CC
Musculoskeletal Transplant Foundation, Inc.
420802
In Commercial Distribution

  • W4184420802T0473 ()

  • 1.0 cc volume
420802

  • Bone matrix implant, human-derived
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