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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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Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 210 cc
Sientra, Inc.
OBASE-210HP
In Commercial Distribution

  • 00819409020430 ()

  • Volume: 210 cc
OBASE-210HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 180 cc
Sientra, Inc.
OBASE-180HP
In Commercial Distribution

  • 00819409020423 ()

  • Volume: 180 cc
OBASE-180HP

  • Silicone gel-filled breast implant, textured-surface
Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CX-300S
In Commercial Distribution

  • 00819409020324 ()

  • Volume: 300-480 cc
FME-CX-300S

  • Skin-port tissue expander
Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CV-300S
In Commercial Distribution

  • 00819409020317 ()

  • Volume: 300-480 cc
FME-CV-300S

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

  • 00819409020300 ()

  • Volume: 200-400 cc
SHR-LR-200S

  • Skin-port tissue expander
Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 150-300 cc
Sientra, Inc.
SHR-LR-150S
In Commercial Distribution

  • 00819409020294 ()

  • Volume: 150-300 cc
SHR-LR-150S

  • Skin-port tissue expander
Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 110-220 cc
Sientra, Inc.
SHR-LR-110S
In Commercial Distribution

  • 00819409020287 ()

  • Volume: 110-220 cc
SHR-LR-110S

  • Skin-port tissue expander
Tissue Expander, Shriners Ellipsoid, Smooth Surface, Remote Port, Reinforced Base, 10-15 cc
Sientra, Inc.
SHR-EL-010S
In Commercial Distribution

  • 00819409020270 ()

  • Volume: 10-15 cc
SHR-EL-010S

  • Skin-port tissue expander
Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 500-1000 cc
Sientra, Inc.
SHR-LR-500S
In Commercial Distribution

  • 00819409020263 ()

  • Volume: 500-1000 cc
SHR-LR-500S

  • Skin-port tissue expander
Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 340-680 cc
Sientra, Inc.
SHR-LR-340S
In Commercial Distribution

  • 00819409020256 ()

  • Volume: 340-680 cc
SHR-LR-340S

  • Skin-port tissue expander
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