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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 High Profile, 205 cc
Sientra, Inc.
10521-205HP
Not in Commercial Distribution

  • 00812790020324 ()

  • Volume: 205 cc
10521-205HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 185 cc
Sientra, Inc.
10521-185HP
Not in Commercial Distribution

  • 00812790020317 ()

  • Volume: 185 cc
10521-185HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 165 cc
Sientra, Inc.
10521-165HP
Not in Commercial Distribution

  • 00812790020300 ()

  • Volume: 165 cc
10521-165HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 135 cc
Sientra, Inc.
10521-135HP
Not in Commercial Distribution

  • 00812790020294 ()

  • Volume: 135 cc
10521-135HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 115 cc
Sientra, Inc.
10521-115HP
Not in Commercial Distribution

  • 00812790020287 ()

  • Volume: 115 cc
10521-115HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 95 cc
Sientra, Inc.
10521-095HP
Not in Commercial Distribution

  • 00812790020270 ()

  • Volume: 95 cc
10521-095HP

  • Silicone gel-filled breast implant, smooth-surface
Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Non-reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FO-025S
In Commercial Distribution

  • 00812790029990 ()

  • Volume: 25-62 cc
SRE-FO-025S

  • Skin-port tissue expander
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, 35-89 cc
Sientra, Inc.
SRE-FO-035
In Commercial Distribution

  • 00812790029969 ()

  • Volume: 35-89 cc
SRE-FO-035

  • Skin-port tissue expander
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