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 Ultra High Profile Silicone Gel-Filled Breast Implant 1340cc
MENTOR TEXAS L.P.
SUHE1340
In Commercial Distribution

  • 10081317031083 ()
SUHE-1340

  • Silicone gel-filled breast implant, smooth-surface
High Profile BOOST, For Use With SHPB-325
MENTOR TEXAS L.P.
RSZHPB325S
In Commercial Distribution

  • 10081317030666 ()
RSZ-HPB-325S

  • Invasive breast implant sizer, fixed, reusable
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 850CC
MENTOR TEXAS L.P.
SCPX154TH
In Commercial Distribution

  • 10081317028472 ()
SCPX-154TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650CC
MENTOR TEXAS L.P.
SCPX140TH
In Commercial Distribution

  • 10081317028458 ()
SCPX-140TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 450CC
MENTOR TEXAS L.P.
SCPX123TH
In Commercial Distribution

  • 10081317028434 ()
SCPX-123TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 250CC
MENTOR TEXAS L.P.
SCPX101TH
In Commercial Distribution

  • 10081317028410 ()
SCPX-101TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 550CC
MENTOR TEXAS L.P.
SCPX135MH
In Commercial Distribution

  • 10081317028380 ()
SCPX-135MH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 450CC
MENTOR TEXAS L.P.
SCPX127MH
In Commercial Distribution

  • 10081317028373 ()
SCPX-127MH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 350CC
MENTOR TEXAS L.P.
SCPX117MH
In Commercial Distribution

  • 10081317028366 ()
SCPX-117MH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 275CC
MENTOR TEXAS L.P.
SCPX107MH
In Commercial Distribution

  • 10081317028359 ()
SCPX-107MH

  • Skin-port tissue expander
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