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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, 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, 600-720 cc
Sientra, Inc.
AlloX2-FH15SE
In Commercial Distribution

  • 00812790028238 ()

  • Volume: 600-720 cc
AlloX2-FH15SE

  • 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, 360-430 cc
Sientra, Inc.
AlloX2-FH13SE
In Commercial Distribution

  • 00812790028214 ()

  • Volume: 360-430 cc
AlloX2-FH13SE

  • 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
Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 230-280 cc
Sientra, Inc.
AlloX2-FH11SE
In Commercial Distribution

  • 00812790028191 ()

  • Volume: 230-280 cc
AlloX2-FH11SE

  • Skin-port tissue expander
Tissue Expander, Rectangular, 3-Valves, Smooth, 500 ml
Sientra, Inc.
810-500U3
Not in Commercial Distribution

  • 00812790022670 ()

  • Total Volume: 500 Milliliter
810-500U3

  • Skin-port tissue expander
Tissue Expander, Rectangular, 3-Valves, Smooth, 400 ml
Sientra, Inc.
810-400U3
Not in Commercial Distribution

  • 00812790022663 ()

  • Total Volume: 400 Milliliter
810-400U3

  • Skin-port tissue expander
Tissue Expander, Rectangular, 3-Valves, Smooth, 320 ml
Sientra, Inc.
810-320U3
Not in Commercial Distribution

  • 00812790022656 ()

  • Total Volume: 320 Milliliter
810-320U3

  • Skin-port tissue expander
Tissue Expander, Rectangular, 3-Valves, Smooth, 250 ml
Sientra, Inc.
810-250U3
Not in Commercial Distribution

  • 00812790022649 ()

  • Total Volume: 250 Milliliter
810-250U3

  • Skin-port tissue expander
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