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, High Profile, 205 cc
Sientra, Inc.
10721-205HP
In Commercial Distribution

  • 00812790024100 ()

  • Volume: 205 cc
10721-205HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 190 cc
Sientra, Inc.
10721-190HP
In Commercial Distribution

  • 00812790024094 ()

  • Volume: 190 cc
10721-190HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Low Projection, 450 cc
Sientra, Inc.
10710-450LP
In Commercial Distribution

  • 00812790024032 ()

  • Volume: 450 cc
10710-450LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Projection, 370 cc
Sientra, Inc.
10710-370LP
In Commercial Distribution

  • 00812790024018 ()

  • Volume: 370 cc
10710-370LP

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 775 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX775
In Commercial Distribution

  • 10081317027932 ()
SMHX-775

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 700 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX700
In Commercial Distribution

  • 10081317027925 ()
SMHX-700

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 630 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX630
In Commercial Distribution

  • 10081317027918 ()
SMHX-630

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 580 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX580
In Commercial Distribution

  • 10081317027901 ()
SMHX-580

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 545 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX545
In Commercial Distribution

  • 10081317027895 ()
SMHX-545

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 500 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX500
In Commercial Distribution

  • 10081317027888 ()
SMHX-500

  • Silicone gel-filled breast implant, smooth-surface
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