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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 Round Base, Moderate Profile, 160 cc
Sientra, Inc.
20646-160MP
Not in Commercial Distribution

  • 00812790023479 ()

  • Volume: 160 cc
20646-160MP

  • Silicone gel-filled breast implant, textured-surface
Tissue Expander, Low Rectangle, Textured Surface, Remote Port, Reinforced Base, 250-500 cc
Sientra, Inc.
SRE-LR-250
In Commercial Distribution

  • 00812790029891 ()

  • Volume: 250-500 cc
SRE-LR-250

  • Skin-port tissue expander
Tissue Expander, Crescent, Smooth Surface, Remote Port, Reinforced Base, 100-200 cc
Sientra, Inc.
SRE-CR-100S
In Commercial Distribution

  • 00812790029846 ()

  • Volume: 100-200 cc
SRE-CR-100S

  • Skin-port tissue expander
Tissue Expander, Crescent, Smooth Surface, Remote Port, Reinforced Base, 45-90 cc
Sientra, Inc.
SRE-CR-045S
In Commercial Distribution

  • 00812790029839 ()

  • Volume: 45-90 cc
SRE-CR-045S

  • Skin-port tissue expander
Tissue Expander, Crescent, Textured Surface, Remote Port, Reinforced Base, 350-700 cc
Sientra, Inc.
SRE-CR-350
In Commercial Distribution

  • 00812790029822 ()

  • Volume: 350-700 cc
SRE-CR-350

  • Skin-port tissue expander
Tissue Expander, Crescent, Textured Surface, Remote Port, Reinforced Base, 100-200 cc
Sientra, Inc.
SRE-CR-100
In Commercial Distribution

  • 00812790029808 ()

  • Volume: 100-200 cc
SRE-CR-100

  • Skin-port tissue expander
Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 270-675 cc
Sientra, Inc.
SRE-FK-270S
In Commercial Distribution

  • 00812790029785 ()

  • Volume: 270-675 cc
SRE-FK-270S

  • Skin-port tissue expander
Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 80-200 cc
Sientra, Inc.
SRE-FK-080S
In Commercial Distribution

  • 00812790029761 ()

  • Volume: 80-200 cc
SRE-FK-080S

  • Skin-port tissue expander
Tissue Expander, Flat Kidney, Smooth Surface, Remote Port, Reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FK-025S
In Commercial Distribution

  • 00812790029754 ()

  • Volume: 25-62 cc
SRE-FK-025S

  • Skin-port tissue expander
Tissue Expander, Flat Kidney, Textured Surface, Remote Port, Reinforced Base, 270-675 cc
Sientra, Inc.
SRE-FK-270
In Commercial Distribution

  • 00812790029747 ()

  • Volume: 270-675 cc
SRE-FK-270

  • Skin-port tissue expander
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