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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, 255 cc
Sientra, Inc.
10621-255MP
In Commercial Distribution

  • 00812790020959 ()

  • Volume: 255 cc
10621-255MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 175 cc
Sientra, Inc.
10621-175MP
In Commercial Distribution

  • 00812790020911 ()

  • Volume: 175 cc
10621-175MP

  • Silicone gel-filled breast implant
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, 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 High Profile, 625 cc
Sientra, Inc.
10521-625HP
In Commercial Distribution

  • 00812790020492 ()

  • Volume: 625 cc
10521-625HP

  • 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
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