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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, 355 cc
Sientra, Inc.
10521-355HP
Not in Commercial Distribution

  • 00812790020393 ()

  • Volume: 355 cc
10521-355HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 335 cc
Sientra, Inc.
10521-335HP
Not in Commercial Distribution

  • 00812790020386 ()

  • Volume: 335 cc
10521-335HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 315 cc
Sientra, Inc.
10521-315HP
Not in Commercial Distribution

  • 00812790020379 ()

  • Volume: 315 cc
10521-315HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 285 cc
Sientra, Inc.
10521-285HP
Not in Commercial Distribution

  • 00812790020362 ()

  • Volume: 285 cc
10521-285HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 265 cc
Sientra, Inc.
10521-265HP
Not in Commercial Distribution

  • 00812790020355 ()

  • Volume: 265 cc
10521-265HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 245 cc
Sientra, Inc.
10521-245HP
Not in Commercial Distribution

  • 00812790020348 ()

  • Volume: 245 cc
10521-245HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 225 cc
Sientra, Inc.
10521-225HP
Not in Commercial Distribution

  • 00812790020331 ()

  • Volume: 225 cc
10521-225HP

  • Silicone gel-filled breast implant, smooth-surface
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
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