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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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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
21 Ga. Winged Needle Infusion Set (5 each)
Sientra, Inc.
WNIS01
In Commercial Distribution

  • 00819409020355 ()

  • Not applicable
WNIS01

  • Skin-port tissue expander
Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CX-300S
In Commercial Distribution

  • 00819409020324 ()

  • Volume: 300-480 cc
FME-CX-300S

  • Skin-port tissue expander
Tissue Expander, Fleming & Mayer Design, Scalp, Smooth Surface, Remote Port, Reinforced Base, 300-480 cc
Sientra, Inc.
FME-CV-300S
In Commercial Distribution

  • 00819409020317 ()

  • Volume: 300-480 cc
FME-CV-300S

  • Skin-port tissue expander
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