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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, 750-900 cc
Sientra, Inc.
AlloX2-FH16E
In Commercial Distribution

  • 00812790028306 ()

  • Volume: 750-900 cc
AlloX2-FH16E

  • 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, Textured Surface, Integrated Ports, Full Height, 480-575 cc
Sientra, Inc.
AlloX2-FH14E
In Commercial Distribution

  • 00812790028283 ()

  • Volume: 480-575 cc
AlloX2-FH14E

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Ports, Full Height, 360-430 cc
Sientra, Inc.
AlloX2-FH13E
In Commercial Distribution

  • 00812790028276 ()

  • Volume: 360-430 cc
AlloX2-FH13E

  • 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
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 340-680 cc
Sientra, Inc.
SRE-LR-340S
In Commercial Distribution

  • 00812790029945 ()

  • Volume: 340-680 cc
SRE-LR-340S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 250-500 cc
Sientra, Inc.
SRE-LR-250S
In Commercial Distribution

  • 00812790029938 ()

  • Volume: 250-500 cc
SRE-LR-250S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SRE-LR-200S
In Commercial Distribution

  • 00812790029921 ()

  • Volume: 200-400 cc
SRE-LR-200S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 160-320 cc
Sientra, Inc.
SRE-LR-160S
In Commercial Distribution

  • 00812790029914 ()

  • Volume: 160-320 cc
SRE-LR-160S

  • Skin-port tissue expander
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