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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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SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022298

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

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022281

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

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022274

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

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022267

Anatomical Controlled Tissue Expander, Double Chamber, ACX, 470 cc
Sientra, Inc.
20799-470ACX
Not in Commercial Distribution

  • 00812790022267 ()

  • Volume: 470 cc
20799-470ACX

  • Skin-port tissue expander

SIENTRA Anatomical Controlled Tissue Expander (ACX) - 00812790022250

Anatomical Controlled Tissue Expander, Double Chamber, ACX, 390 cc
Sientra, Inc.
20799-390ACX
Not in Commercial Distribution

  • 00812790022250 ()

  • Volume: 390 cc
20799-390ACX

  • Skin-port tissue expander

Winged Needle Infusion Set - 00819409020355

21 Ga. Winged Needle Infusion Set (5 each)
Sientra, Inc.
WNIS01
In Commercial Distribution

  • 00819409020355 ()

  • Not applicable
WNIS01

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020324

Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CX-300S
In Commercial Distribution

  • 00819409020324 ()

  • Volume: 300-480 cc
FME-CX-300S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020317

Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CV-300S
In Commercial Distribution

  • 00819409020317 ()

  • Volume: 300-480 cc
FME-CV-300S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020300

Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SHR-LR-200S
In Commercial Distribution

  • 00819409020300 ()

  • Volume: 200-400 cc
SHR-LR-200S

  • Skin-port tissue expander

Softspan Tissue Expander - 00819409020294

Tissue Expander, Shriners Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 150-300 cc
Sientra, Inc.
SHR-LR-150S
In Commercial Distribution

  • 00819409020294 ()

  • Volume: 150-300 cc
SHR-LR-150S

  • Skin-port tissue expander
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