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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 Plus Profile, 95 cc
Sientra, Inc.
10621-095MP
Not in Commercial Distribution

  • 00812790020874 ()

  • Volume: 95 cc
10621-095MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 140 cc
Sientra, Inc.
10610-140LP
Not in Commercial Distribution

  • 00812790020577 ()

  • Volume: 140 cc
10610-140LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 120 cc
Sientra, Inc.
10610-120LP
Not in Commercial Distribution

  • 00812790020560 ()

  • Volume: 120 cc
10610-120LP

  • Silicone gel-filled breast implant, smooth-surface
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, Low Profile, 60 cc
Sientra, Inc.
10610-060LP
Not in Commercial Distribution

  • 00812790020539 ()

  • Volume: 60 cc
10610-060LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 695 cc
Sientra, Inc.
10521-695HP
Not in Commercial Distribution

  • 00812790020522 ()

  • Volume: 695 cc
10521-695HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 655 cc
Sientra, Inc.
10521-655HP
Not in Commercial Distribution

  • 00812790020508 ()

  • Volume: 655 cc
10521-655HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 595 cc
Sientra, Inc.
10521-595HP
Not in Commercial Distribution

  • 00812790020485 ()

  • Volume: 595 cc
10521-595HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 570 cc
Sientra, Inc.
10521-570HP
In Commercial Distribution

  • 00812790020478 ()

  • Volume: 570 cc
10521-570HP

  • Silicone gel-filled breast implant, smooth-surface
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