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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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MENTOR Smooth Round Moderate Profile - 00081317001218

Saline Breast Implant with Diaphragm Valve, 225cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501630
In Commercial Distribution

  • 00081317001218 ()
350-1630

  • Saline-filled breast implant, unstructured, smooth-surface

MENTOR Smooth Round Moderate Profile - 00081317001195

Saline Breast Implant with Diaphragm Valve, 175cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501620
In Commercial Distribution

  • 00081317001195 ()
350-1620

  • Saline-filled breast implant, unstructured, smooth-surface

MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems - 00081317004059

Dome Pack
MENTOR TEXAS L.P.
350-DOMPK
In Commercial Distribution

  • 00081317004059 ()
350-DOMPK

  • Saline-filled breast implant, unstructured, smooth-surface

MENTOR SILTEX CONTOUR PROFILE SPECTRUM - 00081317002161

Post Operatively Adjustable Saline Breast Implant, 550cc
MENTOR TEXAS L.P.
3542514
Not in Commercial Distribution

  • 00081317002161 ()
354-2514

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR SILTEX Round SPECTRUM - 00081317002109

Post-Operatively Adjustable Saline Breast Implant, 375cc
MENTOR TEXAS L.P.
3542460M
Not in Commercial Distribution

  • 00081317002109 ()
354-2460M

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR SILTEX Round SPECTRUM - 00081317002086

Post-Operatively Adjustable Saline Breast Implant, 275cc
MENTOR TEXAS L.P.
3542440M
Not in Commercial Distribution

  • 00081317002086 ()
354-2440M

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR SILTEX Round SPECTRUM - 00081317002079

Post-Operatively Adjustable Saline Breast Implant, 225cc
MENTOR TEXAS L.P.
3542430M
Not in Commercial Distribution

  • 00081317002079 ()
354-2430M

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR SILTEX Round SPECTRUM - 00081317002062

Post-Operatively Adjustable Saline Breast Implant, 175cc
MENTOR TEXAS L.P.
3542420M
Not in Commercial Distribution

  • 00081317002062 ()
354-2420M

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR SILTEX Round SPECTRUM - 00081317002055

Post-Operatively Adjustable Saline Breast Implant, 125cc
MENTOR TEXAS L.P.
3542410M
Not in Commercial Distribution

  • 00081317002055 ()
354-2410M

  • Saline-filled breast implant, unstructured, textured-surface

MENTOR Smooth Round SPECTRUM - 00081317002048

Post Operatively Adjustable Saline Breast Implant, 575cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501490
In Commercial Distribution

  • 00081317002048 ()
350-1490

  • Saline-filled breast implant, unstructured, smooth-surface
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