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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Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 170cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507170MC
In Commercial Distribution

  • 00081317004080 ()
350-7170MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 150cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507150MC
In Commercial Distribution

  • 00081317004073 ()
350-7150MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 130cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507130MC
In Commercial Distribution

  • 00081317004066 ()
350-7130MC

  • Silicone gel-filled breast implant, smooth-surface
Dome Pack
MENTOR TEXAS L.P.
350-DOMPK
In Commercial Distribution

  • 00081317004059 ()
350-DOMPK

  • Saline-filled breast implant, unstructured, smooth-surface
No Description
MENTOR TEXAS L.P.
350-4402
In Commercial Distribution

  • 00081317004042 ()
350-4402

  • Tissue expander injection port locator
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
SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 575cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3545751
In Commercial Distribution

  • 00081317003915 ()
354-5751

  • Silicone gel-filled breast implant, textured-surface
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