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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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Saline Breast Implant, 630cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3503630D
In Commercial Distribution

  • 10081317029158 ()
350-3630D

  • Saline-filled breast implant, unstructured, smooth-surface
Smooth Moderate High Profile Xtra, 310 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX310
In Commercial Distribution

  • 10081317027826 ()
SMHX-310

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 280 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX280
In Commercial Distribution

  • 10081317027819 ()
SMHX-280

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 255 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX255
In Commercial Distribution

  • 10081317027802 ()
SMHX-255

  • Silicone gel-filled breast implant, smooth-surface
Smooth Moderate High Profile Xtra, 230 cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHX230
In Commercial Distribution

  • 10081317027796 ()
SMHX-230

  • Silicone gel-filled breast implant, smooth-surface
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
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
SCALER, DOUBLE END, UNIVERSITY OF TEXAS #103-106, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSC103-106
In Commercial Distribution

  • 00840018621626 ()


  • Manual dental scaler, reusable
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