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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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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, 525 cc
Sientra, Inc.
20645-525MP
In Commercial Distribution

  • 00812790027989 ()

  • Volume: 525 cc
20645-525MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 350 cc
Sientra, Inc.
20645-350MP
In Commercial Distribution

  • 00812790027958 ()

  • Volume: 350 cc
20645-350MP

  • Silicone gel-filled breast implant, textured-surface
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
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 650 cc
Sientra, Inc.
20621-650MP
In Commercial Distribution

  • 00812790024667 ()

  • Volume: 650 cc
20621-650MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 540 cc
Sientra, Inc.
20621-540MP
In Commercial Distribution

  • 00812790024643 ()

  • Volume: 540 cc
20621-540MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 415 cc
Sientra, Inc.
20621-415MP
In Commercial Distribution

  • 00812790024612 ()

  • Volume: 415 cc
20621-415MP

  • Silicone gel-filled breast implant
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