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 Class Implantable

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SITLEX Medium Height Tissue Expander Style 6200, 450cc
MENTOR TEXAS L.P.
3546213
Not in Commercial Distribution

  • 00081317002260 ()
354-6213

  • Skin-port tissue expander
SITLEX Medium Height Tissue Expander Style 6200, 350cc
MENTOR TEXAS L.P.
3546212
Not in Commercial Distribution

  • 00081317002253 ()
354-6212

  • Skin-port tissue expander
SITLEX Medium Height Tissue Expander Style 6200, 275cc
MENTOR TEXAS L.P.
3546211
Not in Commercial Distribution

  • 00081317002246 ()
354-6211

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 750cc
MENTOR TEXAS L.P.
3546116
Not in Commercial Distribution

  • 00081317002239 ()
354-6116

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 650cc
MENTOR TEXAS L.P.
3546115
Not in Commercial Distribution

  • 00081317002222 ()
354-6115

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 550cc
MENTOR TEXAS L.P.
3546114
Not in Commercial Distribution

  • 00081317002215 ()
354-6114

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 450cc
MENTOR TEXAS L.P.
3546113
Not in Commercial Distribution

  • 00081317002208 ()
354-6113

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 350cc
MENTOR TEXAS L.P.
3546112
Not in Commercial Distribution

  • 00081317002192 ()
354-6112

  • Skin-port tissue expander
SILTEX Low Height Tissue Expander Style 6100, 250cc
MENTOR TEXAS L.P.
3546111
Not in Commercial Distribution

  • 00081317002185 ()
354-6111

  • Skin-port tissue expander
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
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