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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 Round, Moderate Plus Profile, 195cc
Sientra, Inc.
20721-195MP
In Commercial Distribution

  • 00812790025558 ()

  • Volume: 195 cc
20721-195MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 175cc
Sientra, Inc.
20721-175MP
In Commercial Distribution

  • 00812790025541 ()

  • Volume: 175 cc
20721-175MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 155cc
Sientra, Inc.
20721-155MP
In Commercial Distribution

  • 00812790025534 ()

  • Volume: 155 cc
20721-155MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 135cc
Sientra, Inc.
20721-135MP
In Commercial Distribution

  • 00812790025527 ()

  • Volume: 135 cc
20721-135MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 115cc
Sientra, Inc.
20721-115MP
In Commercial Distribution

  • 00812790025510 ()

  • Volume: 115 cc
20721-115MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 95cc
Sientra, Inc.
20721-095MP
In Commercial Distribution

  • 00812790025503 ()

  • Volume: 095 cc
20721-095MP

  • Silicone gel-filled breast implant
Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 750-900 cc
Sientra, Inc.
BTE750
In Commercial Distribution

  • 00812790029150 ()

  • Volume: 750-900 cc
BTE750

  • Skin-port tissue expander
Tissue Expander, Rectangle, Textured Surface, Remote Port, Reinforced Base, 500-600 cc
Sientra, Inc.
SPR500
In Commercial Distribution

  • 00812790029143 ()

  • Volume: 500-600 cc
SPR500

  • Skin-port tissue expander
Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 350-420 cc
Sientra, Inc.
BTE350
In Commercial Distribution

  • 00812790029136 ()

  • Volume: 350-420 cc
BTE350

  • Skin-port tissue expander
Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 250-300 cc
Sientra, Inc.
BTE250
In Commercial Distribution

  • 00812790029129 ()

  • Volume: 250-300 cc
BTE250

  • Skin-port tissue expander
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