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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 - 00819409021178

Silicone Gel Breast Implant, Textured Shaped Round Base, High Projection, 550 cc
Sientra, Inc.
RBASE-550HP
In Commercial Distribution

  • 00819409021178 ()

  • Volume: 550 cc
RBASE-550HP

  • Silicone gel-filled breast implant, textured-surface

OPUS Silicone Gel Breast Implant - 00819409021161

Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 515 cc
Sientra, Inc.
RBASE-515HP
In Commercial Distribution

  • 00819409021161 ()

  • Volume: 515 cc
RBASE-515HP

  • Silicone gel-filled breast implant, textured-surface

Softspan Tissue Expander - 00819409020171

Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 750-1400 cc
Sientra, Inc.
SHR-CV-750S
In Commercial Distribution

  • 00819409020171 ()

  • Volume: 750-1400 cc
SHR-CV-750S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020164

Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 720-1080 cc
Sientra, Inc.
SHR-CV-720S
In Commercial Distribution

  • 00819409020164 ()

  • Volume: 720-1080 cc
SHR-CV-720S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020157

Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 520-780 cc
Sientra, Inc.
SHR-CV-520S
In Commercial Distribution

  • 00819409020157 ()

  • Volume: 520-780 cc
SHR-CV-520S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020140

Tissue Expander, Shriners Curvilinear, Smooth Surface, Remote Port, Reinforced Base, 320-480 cc
Sientra, Inc.
SHR-CV-320S
In Commercial Distribution

  • 00819409020140 ()

  • Volume: 320-480 cc
SHR-CV-320S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020133

Tissue Expander, Crescent, Smooth Surface, Integrated Port, Reinforced Base, 350-700 cc
Sientra, Inc.
SIE-CR-350S
In Commercial Distribution

  • 00819409020133 ()

  • Volume: 350-700 cc
SIE-CR-350S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020126

Tissue Expander, Crescent, Smooth Surface, Integrated Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SIE-CR-200S
In Commercial Distribution

  • 00819409020126 ()

  • Volume: 200-400 cc
SIE-CR-200S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020119

Tissue Expander, Crescent, Smooth Surface, Integrated Port, Reinforced Base, 100-200 cc
Sientra, Inc.
SIE-CR-100S
In Commercial Distribution

  • 00819409020119 ()

  • Volume: 100-200 cc
SIE-CR-100S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020102

Tissue Expander, Crescent, Smooth Surface, Integrated Port, Reinforced Base, 45-90 cc
Sientra, Inc.
SIE-CR-045S
In Commercial Distribution

  • 00819409020102 ()

  • Volume: 45-90 cc
SIE-CR-045S

  • Skin-port tissue expander
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