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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, 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
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 270cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545270
In Commercial Distribution

  • 00081317007098 ()
354-5270

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 240cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545240
In Commercial Distribution

  • 00081317007081 ()
354-5240

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 215cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545215
In Commercial Distribution

  • 00081317007074 ()
354-5215

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 185cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545185
In Commercial Distribution

  • 00081317007067 ()
354-5185

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 160cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545160
In Commercial Distribution

  • 00081317007050 ()
354-5160

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 135cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545135
In Commercial Distribution

  • 00081317007043 ()
354-5135

  • Silicone gel-filled breast implant, textured-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 800cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505800BC
In Commercial Distribution

  • 00081317007036 ()
350-5800BC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 750cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3505750BC
In Commercial Distribution

  • 00081317007029 ()
350-5750BC

  • Silicone gel-filled breast implant, smooth-surface
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