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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, 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, Moderate Plus Profile, 155 cc
Sientra, Inc.
10621-155MP
Not in Commercial Distribution

  • 00812790020904 ()

  • Volume: 155 cc
10621-155MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 135 cc
Sientra, Inc.
10621-135MP
Not in Commercial Distribution

  • 00812790020898 ()

  • Volume: 135 cc
10621-135MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 115 cc
Sientra, Inc.
10621-115MP
Not in Commercial Distribution

  • 00812790020881 ()

  • Volume: 115 cc
10621-115MP

  • Silicone gel-filled breast implant, smooth-surface
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, Textured Shaped Round Base, High Profile, 515 cc
Sientra, Inc.
20646-515HP
In Commercial Distribution

  • 00812790026999 ()

  • Volume: 515 cc
20646-515HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, High Profile, 455 cc
Sientra, Inc.
20646-455HP
In Commercial Distribution

  • 00812790026975 ()

  • Volume: 455 cc
20646-455HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, High Profile, 425 cc
Sientra, Inc.
20646-425HP
In Commercial Distribution

  • 00812790026968 ()

  • Volume: 425 cc
20646-425HP

  • Silicone gel-filled breast implant, textured-surface
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