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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 Moderate Classic Profile Gel-Filled Breast Implant, 300cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3543007MC
In Commercial Distribution

  • 00081317004394 ()
354-3007MC

  • 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
Smooth High Profile, 740cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB740
In Commercial Distribution

  • 00081317027140 ()
SHPB-740

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 585cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB585
In Commercial Distribution

  • 00081317027119 ()
SHPB-585

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 545cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB545
In Commercial Distribution

  • 00081317027102 ()
SHPB-545

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 520cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB520
In Commercial Distribution

  • 00081317027096 ()
SHPB-520

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 480cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB480
In Commercial Distribution

  • 00081317027089 ()
SHPB-480

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 440cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB440
In Commercial Distribution

  • 00081317027072 ()
SHPB-440

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 370cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB370
In Commercial Distribution

  • 00081317027058 ()
SHPB-370

  • Silicone gel-filled breast implant, smooth-surface
Smooth High Profile, 260cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SHPB260
In Commercial Distribution

  • 00081317027027 ()
SHPB-260

  • Silicone gel-filled breast implant, smooth-surface
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