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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, 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, 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, 675 cc
Sientra, Inc.
10521-675HP
In Commercial Distribution

  • 00812790020515 ()

  • Volume: 675 cc
10521-675HP

  • 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, 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
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
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 545 cc
Sientra, Inc.
10521-545HP
Not in Commercial Distribution

  • 00812790020461 ()

  • Volume: 545 cc
10521-545HP

  • Silicone gel-filled breast implant, smooth-surface
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