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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, 100 cc
Sientra, Inc.
20610-100LP
In Commercial Distribution

  • 00812790021093 ()

  • Volume: 100 cc
20610-100LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Low Profile, 80 cc
Sientra, Inc.
20610-080LP
Not in Commercial Distribution

  • 00812790021086 ()

  • Volume: 80 cc
20610-080LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Smooth Round, High Profile, 565 cc
Sientra, Inc.
10621-565HP
In Commercial Distribution

  • 00812790020867 ()

  • Volume: 565 cc
10621-565HP

  • Silicone gel-filled breast implant
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, Low Profile, 100 cc
Sientra, Inc.
10610-100LP
Not in Commercial Distribution

  • 00812790020553 ()

  • Volume: 100 cc
10610-100LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 80 cc
Sientra, Inc.
10610-080LP
Not in Commercial Distribution

  • 00812790020546 ()

  • Volume: 80 cc
10610-080LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 320 cc
Sientra, Inc.
10512-320MP
In Commercial Distribution

  • 00812790020126 ()

  • Volume: 320 cc
10512-320MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 270 cc
Sientra, Inc.
10512-270MP
In Commercial Distribution

  • 00812790020096 ()

  • Volume: 270 cc
10512-270MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 210 cc
Sientra, Inc.
10512-210MP
In Commercial Distribution

  • 00812790020065 ()

  • Volume: 210 cc
10512-210MP

  • Silicone gel-filled breast implant
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