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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, 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 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, 545 cc
Sientra, Inc.
10521-545HP
Not in Commercial Distribution

  • 00812790020461 ()

  • Volume: 545 cc
10521-545HP

  • 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, 495 cc
Sientra, Inc.
10521-495HP
Not in Commercial Distribution

  • 00812790020447 ()

  • Volume: 495 cc
10521-495HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 465 cc
Sientra, Inc.
10521-465HP
Not in Commercial Distribution

  • 00812790020430 ()

  • Volume: 465 cc
10521-465HP

  • 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
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