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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, Textured Round, Low Profile, 60 cc
Sientra, Inc.
20610-060LP
Not in Commercial Distribution

  • 00812790021079 ()

  • Volume: 60 cc
20610-060LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Smooth Round, High Profile, 415 cc
Sientra, Inc.
10621-415HP
In Commercial Distribution

  • 00812790020836 ()

  • Volume: 415 cc
10621-415HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 350 cc
Sientra, Inc.
10621-350HP
In Commercial Distribution

  • 00812790020812 ()

  • Volume: 350 cc
10621-350HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 300 cc
Sientra, Inc.
10621-300HP
In Commercial Distribution

  • 00812790020799 ()

  • Volume: 300 cc
10621-300HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 255 cc
Sientra, Inc.
10621-255HP
In Commercial Distribution

  • 00812790020775 ()

  • Volume: 255 cc
10621-255HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 190 cc
Sientra, Inc.
10512-190MP
In Commercial Distribution

  • 00812790020058 ()

  • Volume: 190 cc
10512-190MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 170 cc
Sientra, Inc.
10512-170MP
Not in Commercial Distribution

  • 00812790020041 ()

  • Volume: 170 cc
10512-170MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 150 cc
Sientra, Inc.
10512-150MP
Not in Commercial Distribution

  • 00812790020034 ()

  • Volume: 150 cc
10512-150MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 120 cc
Sientra, Inc.
10512-120MP
Not in Commercial Distribution

  • 00812790020027 ()

  • Volume: 120 cc
10512-120MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 100 cc
Sientra, Inc.
10512-100MP
Not in Commercial Distribution

  • 00812790020010 ()

  • Volume: 100 cc
10512-100MP

  • Silicone gel-filled breast implant, smooth-surface
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