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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SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 385cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3543857MC
In Commercial Distribution

  • 00081317004431 ()
354-3857MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 360cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3543607MC
In Commercial Distribution

  • 00081317004424 ()
354-3607MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 340cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3543407MC
In Commercial Distribution

  • 00081317004417 ()
354-3407MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 255cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3542557MC
In Commercial Distribution

  • 00081317004370 ()
354-2557MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 235cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3542357MC
In Commercial Distribution

  • 00081317004363 ()
354-2357MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 215cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3542157MC
In Commercial Distribution

  • 00081317004356 ()
354-2157MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round High Profile Gel-Filled Breast Implant, 750cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3544750
In Commercial Distribution

  • 00081317003953 ()
354-4750

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round High Profile Gel-Filled Breast Implant, 475cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3544475
In Commercial Distribution

  • 00081317003946 ()
354-4475

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 750cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3547501
In Commercial Distribution

  • 00081317003939 ()
354-7501

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 650cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3546501
In Commercial Distribution

  • 00081317003922 ()
354-6501

  • Silicone gel-filled breast implant, textured-surface
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