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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Smooth Round Moderate Profile Gel-Filled Breast Implant, 550cc
MENTOR TEXAS L.P.
3507550BC
Not in Commercial Distribution

  • 00081317000167 ()
350-7550BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 500cc
MENTOR TEXAS L.P.
3507500BC
Not in Commercial Distribution

  • 00081317000150 ()
350-7500BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 450cc
MENTOR TEXAS L.P.
3507450BC
Not in Commercial Distribution

  • 00081317000143 ()
350-7450BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 400cc
MENTOR TEXAS L.P.
3507400BC
Not in Commercial Distribution

  • 00081317000136 ()
350-7400BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 375cc
MENTOR TEXAS L.P.
3507375BC
Not in Commercial Distribution

  • 00081317000129 ()
350-7375BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 350cc
MENTOR TEXAS L.P.
3507350BC
Not in Commercial Distribution

  • 00081317000112 ()
350-7350BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 325cc
MENTOR TEXAS L.P.
3507325BC
Not in Commercial Distribution

  • 00081317000105 ()
350-7325BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 300cc
MENTOR TEXAS L.P.
3507300BC
Not in Commercial Distribution

  • 00081317000099 ()
350-7300BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 275cc
MENTOR TEXAS L.P.
3507275BC
Not in Commercial Distribution

  • 00081317000082 ()
350-7275BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 250cc
MENTOR TEXAS L.P.
3507250BC
Not in Commercial Distribution

  • 00081317000075 ()
350-7250BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 225cc
MENTOR TEXAS L.P.
3507225BC
Not in Commercial Distribution

  • 00081317000068 ()
350-7225BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 200cc
MENTOR TEXAS L.P.
3507200BC
Not in Commercial Distribution

  • 00081317000051 ()
350-7200BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 175cc
MENTOR TEXAS L.P.
3507175BC
Not in Commercial Distribution

  • 00081317000044 ()
350-7175BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 150cc
MENTOR TEXAS L.P.
3507150BC
Not in Commercial Distribution

  • 00081317000037 ()
350-7150BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 125cc
MENTOR TEXAS L.P.
3507125BC
Not in Commercial Distribution

  • 00081317000020 ()
350-7125BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Profile Gel-Filled Breast Implant, 100cc
MENTOR TEXAS L.P.
3507100BC
Not in Commercial Distribution

  • 00081317000013 ()
350-7100BC

  • Silicone gel-filled breast implant, smooth-surface
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-930
MENTOR TEXAS L.P.
SZUHE930
In Commercial Distribution

  • 10081317032738 ()
SZ-UHE-930

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1445
MENTOR TEXAS L.P.
SZUHE1445
In Commercial Distribution

  • 10081317032721 ()
SZ-UHE-1445

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1340
MENTOR TEXAS L.P.
SZUHE1340
In Commercial Distribution

  • 10081317032714 ()
SZ-UHE-1340

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1240
MENTOR TEXAS L.P.
SZUHE1240
In Commercial Distribution

  • 10081317032707 ()
SZ-UHE-1240

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1135
MENTOR TEXAS L.P.
SZUHE1135
In Commercial Distribution

  • 10081317032691 ()
SZ-UHE-1135

  • Invasive breast implant sizer, fixed, single-use
MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile for use with SUHE-1030
MENTOR TEXAS L.P.
SZUHE1030
In Commercial Distribution

  • 10081317032684 ()
SZ-UHE-1030

  • Invasive breast implant sizer, fixed, single-use
Breast Tissue Expander, Suture Tabs, Integral Injection Dome
MENTOR TEXAS L.P.
SCPX15THE
In Commercial Distribution

  • 10081317032332 ()
SCPX-15TH-E

  • Skin-port tissue expander
Moderate High Profile BOOST, For Use With SMHB-775
MENTOR TEXAS L.P.
RSZMHB775S
In Commercial Distribution

  • 10081317031526 ()
RSZ-MHB-775S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-635
MENTOR TEXAS L.P.
RSZMHB635S
In Commercial Distribution

  • 10081317031502 ()
RSZ-MHB-635S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-500
MENTOR TEXAS L.P.
RSZMHB500S
In Commercial Distribution

  • 10081317031489 ()
RSZ-MHB-500S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-435
MENTOR TEXAS L.P.
RSZMHB435S
In Commercial Distribution

  • 10081317031465 ()
RSZ-MHB-435S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-375
MENTOR TEXAS L.P.
RSZMHB375S
In Commercial Distribution

  • 10081317031441 ()
RSZ-MHB-375S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-330
MENTOR TEXAS L.P.
RSZMHB330S
In Commercial Distribution

  • 10081317031427 ()
RSZ-MHB-330S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-310
MENTOR TEXAS L.P.
RSZMHB310S
In Commercial Distribution

  • 10081317031410 ()
RSZ-MHB-310S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-280
MENTOR TEXAS L.P.
RSZMHB280S
In Commercial Distribution

  • 10081317031403 ()
RSZ-MHB-280S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-230
MENTOR TEXAS L.P.
RSZMHB230S
In Commercial Distribution

  • 10081317031380 ()
RSZ-MHB-230S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-190
MENTOR TEXAS L.P.
RSZMHB190S
In Commercial Distribution

  • 10081317031366 ()
RSZ-MHB-190S

  • Invasive breast implant sizer, fixed, reusable
Moderate High Profile BOOST, For Use With SMHB-545
MENTOR TEXAS L.P.
RSZMHB545S
In Commercial Distribution

  • 10081317031328 ()
RSZ-MHB-545S

  • Invasive breast implant sizer, fixed, reusable
Smooth Moderate High Profile, 700cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB700
In Commercial Distribution

  • 10081317031304 ()
SMHB-700

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 375cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB375
In Commercial Distribution

  • 10081317031274 ()
SMHB-375

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 355cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB355
In Commercial Distribution

  • 10081317031267 ()
SMHB-355

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 280cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB280
In Commercial Distribution

  • 10081317031236 ()
SMHB-280

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 230cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB230
In Commercial Distribution

  • 10081317031212 ()
SMHB-230

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 210cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB210
In Commercial Distribution

  • 10081317031205 ()
SMHB-210

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 190cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB190
In Commercial Distribution

  • 10081317031199 ()
SMHB-190

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 170cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB170
In Commercial Distribution

  • 10081317031182 ()
SMHB-170

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 150cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB150
In Commercial Distribution

  • 10081317031175 ()
SMHB-150

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 545cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB545
In Commercial Distribution

  • 10081317031151 ()
SMHB-545

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 500cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB500
In Commercial Distribution

  • 10081317031144 ()
SMHB-500

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 470cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB470
In Commercial Distribution

  • 10081317031137 ()
SMHB-470

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile, 435cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB435
In Commercial Distribution

  • 10081317031113 ()
SMHB-435

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1445cc
MENTOR TEXAS L.P.
SUHE1445
In Commercial Distribution

  • 10081317031090 ()
SUHE-1445

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1135cc
MENTOR TEXAS L.P.
SUHE1135
In Commercial Distribution

  • 10081317031069 ()
SUHE-1135

  • Silicone gel-filled breast implant, smooth-surface
Smooth Ultra High Profile Silicone Gel-Filled Breast Implant 1030cc
MENTOR TEXAS L.P.
SUHE1030
In Commercial Distribution

  • 10081317031052 ()
SUHE-1030

  • Silicone gel-filled breast implant, smooth-surface
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