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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, 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
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 425 cc
Sientra, Inc.
10512-425MP
In Commercial Distribution

  • 00812790020195 ()

  • Volume: 425 cc
10512-425MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 395 cc
Sientra, Inc.
10512-395MP
In Commercial Distribution

  • 00812790020171 ()

  • Volume: 395 cc
10512-395MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 365 cc
Sientra, Inc.
10512-365MP
In Commercial Distribution

  • 00812790020157 ()

  • Volume: 365 cc
10512-365MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 335 cc
Sientra, Inc.
10512-335MP
In Commercial Distribution

  • 00812790020133 ()

  • Volume: 335 cc
10512-335MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 285 cc
Sientra, Inc.
10512-285MP
In Commercial Distribution

  • 00812790020102 ()

  • Volume: 285 cc
10512-285MP

  • Silicone gel-filled breast implant, smooth-surface
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