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 Type Device Class Implantable

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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
Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 70-90 cc
Sientra, Inc.
BTE070
In Commercial Distribution

  • 00812790029112 ()

  • Volume: 70-90 cc
BTE070

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Non-reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FO-025S
In Commercial Distribution

  • 00812790029990 ()

  • Volume: 25-62 cc
SRE-FO-025S

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 75-188 cc
Sientra, Inc.
SRE-FO-075
In Commercial Distribution

  • 00812790029983 ()

  • Volume: 75-188 cc
SRE-FO-075

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 60-150 cc
Sientra, Inc.
SRE-FO-060
In Commercial Distribution

  • 00812790029976 ()

  • Volume: 60-150 cc
SRE-FO-060

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Non-reinforced Base, 35-89 cc
Sientra, Inc.
SRE-FO-035
In Commercial Distribution

  • 00812790029969 ()

  • Volume: 35-89 cc
SRE-FO-035

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Non-reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FO-025
In Commercial Distribution

  • 00812790029952 ()

  • Volume: 25-62 cc
SRE-FO-025

  • Skin-port tissue expander
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