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 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, 520 cc
Sientra, Inc.
10521-520HP
In Commercial Distribution

  • 00812790020454 ()

  • Volume: 520 cc
10521-520HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 435 cc
Sientra, Inc.
10521-435HP
Not in Commercial Distribution

  • 00812790020423 ()

  • Volume: 435 cc
10521-435HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 405 cc
Sientra, Inc.
10521-405HP
Not in Commercial Distribution

  • 00812790020416 ()

  • Volume: 405 cc
10521-405HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 375 cc
Sientra, Inc.
10521-375HP
Not in Commercial Distribution

  • 00812790020409 ()

  • Volume: 375 cc
10521-375HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 225 cc
Sientra, Inc.
10521-225HP
Not in Commercial Distribution

  • 00812790020331 ()

  • Volume: 225 cc
10521-225HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 205 cc
Sientra, Inc.
10521-205HP
Not in Commercial Distribution

  • 00812790020324 ()

  • Volume: 205 cc
10521-205HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 165 cc
Sientra, Inc.
10521-165HP
Not in Commercial Distribution

  • 00812790020300 ()

  • Volume: 165 cc
10521-165HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 135 cc
Sientra, Inc.
10521-135HP
Not in Commercial Distribution

  • 00812790020294 ()

  • Volume: 135 cc
10521-135HP

  • Silicone gel-filled breast implant, smooth-surface
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