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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SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 240cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545240
In Commercial Distribution

  • 00081317007081 ()
354-5240

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 215cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545215
In Commercial Distribution

  • 00081317007074 ()
354-5215

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 185cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545185
In Commercial Distribution

  • 00081317007067 ()
354-5185

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 160cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545160
In Commercial Distribution

  • 00081317007050 ()
354-5160

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 135cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545135
In Commercial Distribution

  • 00081317007043 ()
354-5135

  • Silicone gel-filled breast implant, textured-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 800cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505800BC
In Commercial Distribution

  • 00081317007036 ()
350-5800BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 750cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505750BC
In Commercial Distribution

  • 00081317007029 ()
350-5750BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 700cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505700BC
In Commercial Distribution

  • 00081317007012 ()
350-5700BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 650cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505650BC
In Commercial Distribution

  • 00081317007005 ()
350-5650BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 590cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505590BC
In Commercial Distribution

  • 00081317006992 ()
350-5590BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 535cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505535BC
In Commercial Distribution

  • 00081317006985 ()
350-5535BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 480cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505480BC
In Commercial Distribution

  • 00081317006978 ()
350-5480BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 455cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505455BC
In Commercial Distribution

  • 00081317006961 ()
350-5455BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 430cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505430BC
In Commercial Distribution

  • 00081317006954 ()
350-5430BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 400cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505400BC
In Commercial Distribution

  • 00081317006947 ()
350-5400BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 375cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505375BC
In Commercial Distribution

  • 00081317006930 ()
350-5375BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 350cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505350BC
In Commercial Distribution

  • 00081317006923 ()
350-5350BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 320cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505320BC
In Commercial Distribution

  • 00081317006916 ()
350-5320BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 295cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505295BC
In Commercial Distribution

  • 00081317006909 ()
350-5295BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 270cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505270BC
In Commercial Distribution

  • 00081317006893 ()
350-5270BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 240cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505240BC
In Commercial Distribution

  • 00081317006886 ()
350-5240BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 215cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505215BC
In Commercial Distribution

  • 00081317006879 ()
350-5215BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 185cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505185BC
In Commercial Distribution

  • 00081317006862 ()
350-5185BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 160cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505160BC
In Commercial Distribution

  • 00081317006855 ()
350-5160BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 135cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505135BC
In Commercial Distribution

  • 00081317006848 ()
350-5135BC

  • Silicone gel-filled breast implant, smooth-surface
SILTEX Tall Height Tissue Expander Style 9300, 850cc
MENTOR TEXAS L.P.
3549317
In Commercial Distribution

  • 00081317006831 ()
354-9317

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 750cc
MENTOR TEXAS L.P.
3549316
In Commercial Distribution

  • 00081317006824 ()
354-9316

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 650cc
MENTOR TEXAS L.P.
3549315
In Commercial Distribution

  • 00081317006817 ()
354-9315

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 550cc
MENTOR TEXAS L.P.
3549314
In Commercial Distribution

  • 00081317006800 ()
354-9314

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 450cc
MENTOR TEXAS L.P.
3549313
In Commercial Distribution

  • 00081317006794 ()
354-9313

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 350cc
MENTOR TEXAS L.P.
3549312
In Commercial Distribution

  • 00081317006787 ()
354-9312

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 9300, 250cc
MENTOR TEXAS L.P.
3549311
In Commercial Distribution

  • 00081317006770 ()
354-9311

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 800cc
MENTOR TEXAS L.P.
3549216
In Commercial Distribution

  • 00081317006763 ()
354-9216

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 650cc
MENTOR TEXAS L.P.
3549215
In Commercial Distribution

  • 00081317006756 ()
354-9215

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 550cc
MENTOR TEXAS L.P.
3549214
In Commercial Distribution

  • 00081317006749 ()
354-9214

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 450cc
MENTOR TEXAS L.P.
3549213
In Commercial Distribution

  • 00081317006732 ()
354-9213

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 350cc
MENTOR TEXAS L.P.
3549212
In Commercial Distribution

  • 00081317006725 ()
354-9212

  • Skin-port tissue expander
SILTEX Medium Height Tissue Expander Style 9200, 275cc
MENTOR TEXAS L.P.
3549211
In Commercial Distribution

  • 00081317006718 ()
354-9211

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 750cc
MENTOR TEXAS L.P.
3549116
In Commercial Distribution

  • 00081317006701 ()
354-9116

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 650cc
MENTOR TEXAS L.P.
3549115
In Commercial Distribution

  • 00081317006695 ()
354-9115

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 550cc
MENTOR TEXAS L.P.
3549114
In Commercial Distribution

  • 00081317006688 ()
354-9114

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 450cc
MENTOR TEXAS L.P.
3549113
In Commercial Distribution

  • 00081317006671 ()
354-9113

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 350cc
MENTOR TEXAS L.P.
3549112
In Commercial Distribution

  • 00081317006664 ()
354-9112

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 9100, 250cc
MENTOR TEXAS L.P.
3549111
In Commercial Distribution

  • 00081317006657 ()
354-9111

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 850cc
MENTOR TEXAS L.P.
3548317
In Commercial Distribution

  • 00081317006640 ()
354-8317

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 750cc
MENTOR TEXAS L.P.
3548316
In Commercial Distribution

  • 00081317006633 ()
354-8316

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 650cc
MENTOR TEXAS L.P.
3548315
In Commercial Distribution

  • 00081317006626 ()
354-8315

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 550cc
MENTOR TEXAS L.P.
3548314
In Commercial Distribution

  • 00081317006619 ()
354-8314

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 450cc
MENTOR TEXAS L.P.
3548313
In Commercial Distribution

  • 00081317006602 ()
354-8313

  • Skin-port tissue expander
SILTEX Tall Height Tissue Expander Style 8300, 350cc
MENTOR TEXAS L.P.
3548312
In Commercial Distribution

  • 00081317006596 ()
354-8312

  • Skin-port tissue expander
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