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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, Round, 3-Valves, Smooth, 600 ml
Sientra, Inc.
800-600U3
Not in Commercial Distribution

  • 00812790022366 ()

  • Total Volume: 600 Milliliter
800-600U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 500 ml
Sientra, Inc.
800-500U3
Not in Commercial Distribution

  • 00812790022359 ()

  • Total Volume: 500 Milliliter
800-500U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 400 ml
Sientra, Inc.
800-400U3
Not in Commercial Distribution

  • 00812790022342 ()

  • Total Volume: 400 Milliliter
800-400U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 300 ml
Sientra, Inc.
800-300U3
Not in Commercial Distribution

  • 00812790022335 ()

  • Total Volume: 300 Milliliter
800-300U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 200 ml
Sientra, Inc.
800-200U3
Not in Commercial Distribution

  • 00812790022328 ()

  • Total Volume: 200 Milliliter
800-200U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 100 ml
Sientra, Inc.
800-100U3
Not in Commercial Distribution

  • 00812790022311 ()

  • Total Volume: 100 Milliliter
800-100U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 50 ml
Sientra, Inc.
800-050U3
Not in Commercial Distribution

  • 00812790022304 ()

  • Total Volume: 50 Milliliter
800-050U3

  • Skin-port tissue expander
Anatomical Controlled Tissue Expander, Double Chamber, ACX, 780 cc
Sientra, Inc.
20799-780ACX
Not in Commercial Distribution

  • 00812790022298 ()

  • Volume: 780 cc
20799-780ACX

  • Skin-port tissue expander
Anatomical Controlled Tissue Expander, Double Chamber, ACX, 620 cc
Sientra, Inc.
20799-620ACX
Not in Commercial Distribution

  • 00812790022281 ()

  • Volume: 620 cc
20799-620ACX

  • Skin-port tissue expander
Anatomical Controlled Tissue Expander, Double Chamber, ACX, 570 cc
Sientra, Inc.
20799-570ACX
Not in Commercial Distribution

  • 00812790022274 ()

  • Volume: 570 cc
20799-570ACX

  • Skin-port tissue expander
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