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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, Textured Shaped Round Base, Moderate Profile, 160 cc
Sientra, Inc.
20646-160MP
Not in Commercial Distribution

  • 00812790023479 ()

  • Volume: 160 cc
20646-160MP

  • Silicone gel-filled breast implant, textured-surface
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 275 cc
Sientra, Inc.
20942-160U
Not in Commercial Distribution

  • 00812790023042 ()

  • Volume: 275 cc
20942-160U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 145 cc
Sientra, Inc.
20942-135U
Not in Commercial Distribution

  • 00812790023028 ()

  • Volume: 145 cc
20942-135U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 385 cc
Sientra, Inc.
20922-168U
Not in Commercial Distribution

  • 00812790023004 ()

  • Volume: 385 cc
20922-168U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Low Projection, Textured, 260 cc
Sientra, Inc.
20922-155U
Not in Commercial Distribution

  • 00812790022977 ()

  • Volume: 260 cc
20922-155U

  • Silicone-block tissue reconstructive material
Silicone Gel Breast Implant, Textured Shaped Round Base, 425 cc
Sientra, Inc.
20646-425RB
Not in Commercial Distribution

  • 00812790021956 ()

  • Volume: 425 cc
20646-425RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, 320 cc
Sientra, Inc.
20646-320RB
Not in Commercial Distribution

  • 00812790021932 ()

  • Volume: 320 cc
20646-320RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, 235 cc
Sientra, Inc.
20646-235RB
Not in Commercial Distribution

  • 00812790021901 ()

  • Volume: 235 cc
20646-235RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, 200 cc
Sientra, Inc.
20646-200RB
Not in Commercial Distribution

  • 00812790021888 ()

  • Volume: 200 cc
20646-200RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 650 cc
Sientra, Inc.
20645-650MP
Not in Commercial Distribution

  • 00812790021864 ()

  • Volume: 650 cc
20645-650MP

  • Silicone gel-filled breast implant, textured-surface
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