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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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Smooth Moderate High Profile Xtra, 210 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX210
In Commercial Distribution

  • 10081317027789 ()
SMHX-210

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 185 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX185
In Commercial Distribution

  • 10081317027772 ()
SMHX-185

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 170 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX170
In Commercial Distribution

  • 10081317027765 ()
SMHX-170

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 150 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX150
In Commercial Distribution

  • 10081317027758 ()
SMHX-150

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 130 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX130
In Commercial Distribution

  • 10081317027741 ()
SMHX-130

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 330 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX330
In Commercial Distribution

  • 10081317027734 ()
SMHX-330

  • Silicone gel-filled breast implant, smooth-surface
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
Blood Glucose Test Strips
FORACARE TEXAS, INC
V8/V9
In Commercial Distribution

  • 00816042012747 ()
  • 80816042012743 ()


  • Glucose IVD, kit, electrometry
Blood Glucose Monitoring System
FORACARE TEXAS, INC
V9
In Commercial Distribution

  • 00816042012730 ()


  • Glucose analyser IVD, home-use
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