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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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Silicone Gel Breast Implant, Smooth Round, High Profile, 205 cc
Sientra, Inc.
10721-205HP
In Commercial Distribution

  • 00812790024100 ()

  • Volume: 205 cc
10721-205HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 190 cc
Sientra, Inc.
10721-190HP
In Commercial Distribution

  • 00812790024094 ()

  • Volume: 190 cc
10721-190HP

  • Silicone gel-filled breast implant
4.0MM X 36MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3836
In Commercial Distribution

  • 18257200064656 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 42MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3842
In Commercial Distribution

  • 18257200020072 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 40MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3840
In Commercial Distribution

  • 18257200020065 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 38MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3838
In Commercial Distribution

  • 18257200020041 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 34MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3834
In Commercial Distribution

  • 18257200020034 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 32MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3832
In Commercial Distribution

  • 18257200020027 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 30MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3830
In Commercial Distribution

  • 18257200020010 ()


  • Bone-screw internal spinal fixation system, non-sterile
4.0MM X 28MM C-C BIASED ANGLE SCREW, ASCENT LE POCT
Orthofix US LLC
66-3828
In Commercial Distribution

  • 18257200020003 ()


  • Bone-screw internal spinal fixation system, non-sterile
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