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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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Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 510 cc
Sientra, Inc.
10712-510MP
In Commercial Distribution

  • 00812790026180 ()

  • Volume: 510 cc
10712-510MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 470 cc
Sientra, Inc.
10712-470MP
In Commercial Distribution

  • 00812790026173 ()

  • Volume: 470 cc
10712-470MP

  • Silicone gel-filled breast implant, smooth-surface
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 75-188 cc
Sientra, Inc.
SRE-FO-075
In Commercial Distribution

  • 00812790029983 ()

  • Volume: 75-188 cc
SRE-FO-075

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 60-150 cc
Sientra, Inc.
SRE-FO-060
In Commercial Distribution

  • 00812790029976 ()

  • Volume: 60-150 cc
SRE-FO-060

  • 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, Wedge, Smooth Surface, Remote Port, Non-Reinforced Base, 100-120 cc
Sientra, Inc.
SRE-WG-100S
In Commercial Distribution

  • 00812790029631 ()

  • Volume: 100-120 cc
SRE-WG-100S

  • Skin-port tissue expander
Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 860-1020 cc
Sientra, Inc.
SRE-RD-860S
In Commercial Distribution

  • 00812790029600 ()

  • Volume: 860-1020 cc
SRE-RD-860S

  • Skin-port tissue expander
Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 640-750 cc
Sientra, Inc.
SRE-RD-640S
In Commercial Distribution

  • 00812790029587 ()

  • Volume: 640-750 cc
SRE-RD-640S

  • Skin-port tissue expander
Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 380-430 cc
Sientra, Inc.
SRE-RD-380S
In Commercial Distribution

  • 00812790029556 ()

  • Volume: 380-430 cc
SRE-RD-380S

  • Skin-port tissue expander
Tissue Expander, Round, Smooth Surface, Remote Port, Reinforced Base, 320-380 cc
Sientra, Inc.
SRE-RD-320S
In Commercial Distribution

  • 00812790029549 ()

  • Volume: 320-380 cc
SRE-RD-320S

  • Skin-port tissue expander
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