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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 Round Ultra High Profile Silicone Gel-Filled Breast Implant, 590cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545590
In Commercial Distribution

  • 00081317007197 ()
354-5590

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 535cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545535
In Commercial Distribution

  • 00081317007180 ()
354-5535

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 480cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545480
In Commercial Distribution

  • 00081317007173 ()
354-5480

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 455cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545455
In Commercial Distribution

  • 00081317007166 ()
354-5455

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 430cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545430
In Commercial Distribution

  • 00081317007159 ()
354-5430

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 400cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545400
In Commercial Distribution

  • 00081317007142 ()
354-5400

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 375cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545375
In Commercial Distribution

  • 00081317007135 ()
354-5375

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 350cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545350
In Commercial Distribution

  • 00081317007128 ()
354-5350

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 320cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545320
In Commercial Distribution

  • 00081317007111 ()
354-5320

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 295cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545295
In Commercial Distribution

  • 00081317007104 ()
354-5295

  • Silicone gel-filled breast implant, textured-surface
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