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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Saline Breast Implant, 525cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501685D
In Commercial Distribution

  • 10081317029004 ()
350-1685D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 475cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501680D
In Commercial Distribution

  • 10081317028991 ()
350-1680D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 425cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501670D
In Commercial Distribution

  • 10081317028984 ()
350-1670D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 375cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501660D
In Commercial Distribution

  • 10081317028977 ()
350-1660D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 210cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3503210D
In Commercial Distribution

  • 10081317028960 ()
350-3210D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 190cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3503190D
In Commercial Distribution

  • 10081317028953 ()
350-3190D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 350cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501655D
In Commercial Distribution

  • 10081317028946 ()
350-1655D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 170cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3503170D
In Commercial Distribution

  • 10081317028939 ()
350-3170D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 800cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502800D
In Commercial Distribution

  • 10081317028861 ()
350-2800D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 750cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502750D
In Commercial Distribution

  • 10081317028854 ()
350-2750D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 700cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502700D
In Commercial Distribution

  • 10081317028847 ()
350-2700D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 650cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502650D
In Commercial Distribution

  • 10081317028830 ()
350-2650D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 600cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502600D
In Commercial Distribution

  • 10081317028823 ()
350-2600D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 550cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502550D
In Commercial Distribution

  • 10081317028816 ()
350-2550D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 500cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502500D
In Commercial Distribution

  • 10081317028809 ()
350-2500D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 475cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502475D
In Commercial Distribution

  • 10081317028793 ()
350-2475D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 200cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502200D
In Commercial Distribution

  • 10081317028786 ()
350-2200D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 175cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502175D
In Commercial Distribution

  • 10081317028779 ()
350-2175D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 450cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502450D
In Commercial Distribution

  • 10081317028762 ()
350-2450D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 425cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502425D
In Commercial Distribution

  • 10081317028755 ()
350-2425D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 400cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502400D
In Commercial Distribution

  • 10081317028748 ()
350-2400D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 375cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502375D
In Commercial Distribution

  • 10081317028731 ()
350-2375D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 350cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502350D
In Commercial Distribution

  • 10081317028724 ()
350-2350D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 325cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502325D
In Commercial Distribution

  • 10081317028717 ()
350-2325D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 300cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502300D
In Commercial Distribution

  • 10081317028700 ()
350-2300D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 275cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502275D
In Commercial Distribution

  • 10081317028694 ()
350-2275D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 250cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502250D
In Commercial Distribution

  • 10081317028687 ()
350-2250D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 225cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3502225D
In Commercial Distribution

  • 10081317028670 ()
350-2225D

  • Saline-filled breast implant, unstructured, smooth-surface
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 850CC
MENTOR TEXAS L.P.
SCPX154TH
In Commercial Distribution

  • 10081317028472 ()
SCPX-154TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 750CC
MENTOR TEXAS L.P.
SCPX146TH
In Commercial Distribution

  • 10081317028465 ()
SCPX-146TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650CC
MENTOR TEXAS L.P.
SCPX140TH
In Commercial Distribution

  • 10081317028458 ()
SCPX-140TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 550CC
MENTOR TEXAS L.P.
SCPX132TH
In Commercial Distribution

  • 10081317028441 ()
SCPX-132TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 450CC
MENTOR TEXAS L.P.
SCPX123TH
In Commercial Distribution

  • 10081317028434 ()
SCPX-123TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 350CC
MENTOR TEXAS L.P.
SCPX113TH
In Commercial Distribution

  • 10081317028427 ()
SCPX-113TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 250CC
MENTOR TEXAS L.P.
SCPX101TH
In Commercial Distribution

  • 10081317028410 ()
SCPX-101TH

  • Skin-port tissue expander
Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 800CC
MENTOR TEXAS L.P.
SCPX156MH
In Commercial Distribution

  • 10081317028403 ()
SCPX-156MH

  • Skin-port tissue expander
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex
Texas Medplast, LLC
SM03
In Commercial Distribution

  • 10850025566169 ()
  • 00850025566162 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear loops to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex
Texas Medplast, LLC
SM01
In Commercial Distribution

  • 10850025566138 ()
  • 00850025566131 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
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 Moderate Classic Profile Gel-Filled Breast Implant, 190cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3541907MC
In Commercial Distribution

  • 00081317004349 ()
354-1907MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 170cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3541707MC
In Commercial Distribution

  • 00081317004332 ()
354-1707MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 150cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3541507MC
In Commercial Distribution

  • 00081317004325 ()
354-1507MC

  • Silicone gel-filled breast implant, textured-surface
SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 130cc |Textured|Round|Silicone|
MENTOR TEXAS L.P.
3541307MC
In Commercial Distribution

  • 00081317004318 ()
354-1307MC

  • Silicone gel-filled breast implant, textured-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 800cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507800MC
In Commercial Distribution

  • 00081317004301 ()
350-7800MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 750cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507750MC
In Commercial Distribution

  • 00081317004295 ()
350-7750MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 680cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507680MC
In Commercial Distribution

  • 00081317004288 ()
350-7680MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 640cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507640MC
In Commercial Distribution

  • 00081317004271 ()
350-7640MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 595cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507595MC
In Commercial Distribution

  • 00081317004264 ()
350-7595MC

  • Silicone gel-filled breast implant, smooth-surface
Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 555cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
3507555MC
In Commercial Distribution

  • 00081317004257 ()
350-7555MC

  • Silicone gel-filled breast implant, smooth-surface
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