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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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MemoryGel Xtra Moderate High (MHX) Smooth Sizer 170cc
MENTOR TEXAS L.P.
RSZSMHX170S
In Commercial Distribution

  • 10081317027963 ()
RSZ-SMHX-170S

  • Invasive breast implant sizer, fixed, reusable
MemoryGel Xtra Moderate High (MHX) Smooth Sizer 150cc
MENTOR TEXAS L.P.
RSZSMHX150S
In Commercial Distribution

  • 10081317027956 ()
RSZ-SMHX-150S

  • Invasive breast implant sizer, fixed, reusable
MemoryGel Xtra Moderate High (MHX) Smooth Sizer 130cc
MENTOR TEXAS L.P.
RSZSMHX130S
In Commercial Distribution

  • 10081317027949 ()
RSZ-SMHX-130S

  • Invasive breast implant sizer, fixed, reusable
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
Blood Glucose Monitoring System
FORACARE TEXAS, INC
V8
In Commercial Distribution

  • 00816042012723 ()


  • Glucose analyser IVD, home-use
Medium Height, Moderate Plus Profile Sterile, MM+ 475cc Gel Sizer
MENTOR TEXAS L.P.
RSZ1355S
In Commercial Distribution

  • 00081317008606 ()
RSZ-1355S

  • Invasive breast implant sizer, fixed, reusable
Medium Height, Moderate Plus Profile Sterile, MM+ 420cc Gel Sizer
MENTOR TEXAS L.P.
RSZ1305S
In Commercial Distribution

  • 00081317008590 ()
RSZ-1305S

  • Invasive breast implant sizer, fixed, reusable
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