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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, High Profile, 220 cc
Sientra, Inc.
20646-220HP
In Commercial Distribution

  • 00812790026876 ()

  • Volume: 220 cc
20646-220HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, High Profile, 200 cc
Sientra, Inc.
20646-200HP
In Commercial Distribution

  • 00812790026869 ()

  • Volume: 200 cc
20646-200HP

  • Silicone gel-filled breast implant, textured-surface
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
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 625 cc
Sientra, Inc.
20645-625MP
In Commercial Distribution

  • 00812790028009 ()

  • Volume: 625 cc
20645-625MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 575 cc
Sientra, Inc.
20645-575MP
In Commercial Distribution

  • 00812790027996 ()

  • Volume: 575 cc
20645-575MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 525 cc
Sientra, Inc.
20645-525MP
In Commercial Distribution

  • 00812790027989 ()

  • Volume: 525 cc
20645-525MP

  • Silicone gel-filled breast implant, textured-surface
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