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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, Smooth Surface, Integrated Ports, Mid Height, 225-280 cc
Sientra, Inc.
AlloX2-12SE
In Commercial Distribution

  • 00812790028313 ()

  • Volume: 225-280 cc
AlloX2-12SE

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Ports, Full Height, 600-750 cc
Sientra, Inc.
AlloX2-FH15E
In Commercial Distribution

  • 00812790028290 ()

  • Volume: 600-750 cc
AlloX2-FH15E

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 750-900 cc
Sientra, Inc.
AlloX2-FH16SE
In Commercial Distribution

  • 00812790028245 ()

  • Volume: 750-900 cc
AlloX2-FH16SE

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 480-575 cc
Sientra, Inc.
AlloX2-FH14SE
In Commercial Distribution

  • 00812790028221 ()

  • Volume: 480-575 cc
AlloX2-FH14SE

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 270-330 cc
Sientra, Inc.
AlloX2-FH12SE
In Commercial Distribution

  • 00812790028207 ()

  • Volume: 270-330 cc
AlloX2-FH12SE

  • Skin-port tissue expander
Silicone Gel Breast Implant, Textured Round, Moderate Projection, 150 cc
Sientra, Inc.
20712-150MP
In Commercial Distribution

  • 00812790026593 ()

  • Volume: 150 cc
20712-150MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Moderate Projection, 100 cc
Sientra, Inc.
20712-100MP
In Commercial Distribution

  • 00812790026579 ()

  • Volume: 100 cc
20712-100MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Moderate Projection, 700 cc
Sientra, Inc.
20612-700MP
In Commercial Distribution

  • 00812790026524 ()

  • Volume: 700 cc
20612-700MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Moderate Projection, 600 cc
Sientra, Inc.
20612-600MP
In Commercial Distribution

  • 00812790026500 ()

  • Volume: 600 cc
20612-600MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Moderate Projection, 510 cc
Sientra, Inc.
20612-510MP
In Commercial Distribution

  • 00812790026487 ()

  • Volume: 510 cc
20612-510MP

  • Silicone gel-filled breast implant, textured-surface
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