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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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SILTEX Moderate Plus Profile Xtra Silicone Gel-Filled Breast Implant, 130cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
TMPX130
In Commercial Distribution

  • 00081317025399 ()
TMPX-130

  • Silicone gel-filled breast implant, textured-surface
SILTEX Moderate Plus Profile Xtra Silicone Gel-Filled Breast Implant, 115cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
TMPX115
In Commercial Distribution

  • 00081317025382 ()
TMPX-115

  • Silicone gel-filled breast implant, textured-surface
Smooth High Profile Xtra 490cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX490
In Commercial Distribution

  • 00081317025306 ()
SHPX-490

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 465cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX465
In Commercial Distribution

  • 00081317025290 ()
SHPX-465

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 335cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX335
In Commercial Distribution

  • 00081317025245 ()
SHPX-335

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 285cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX285
In Commercial Distribution

  • 00081317025238 ()
SHPX-285

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 260cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX260
In Commercial Distribution

  • 00081317025221 ()
SHPX-260

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 200cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX200
In Commercial Distribution

  • 00081317025207 ()
SHPX-200

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile Xtra 150cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPX150
In Commercial Distribution

  • 00081317025184 ()
SHPX-150

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate Plus Profile Xtra 685cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMPX685
In Commercial Distribution

  • 00081317025160 ()
SMPX-685

  • Silicone gel-filled breast implant, smooth-surface
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