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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, Round, Single Projection, Smooth, 440 cc
Sientra, Inc.
932-130U
Not in Commercial Distribution

  • 00812790023127 ()

  • Volume: 440 cc
932-130U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 340 cc
Sientra, Inc.
932-125U
Not in Commercial Distribution

  • 00812790023110 ()

  • Volume: 340 cc
932-125U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 290 cc
Sientra, Inc.
932-120U
Not in Commercial Distribution

  • 00812790023103 ()

  • Volume: 290 cc
932-120U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 250 cc
Sientra, Inc.
932-115U
Not in Commercial Distribution

  • 00812790023097 ()

  • Volume: 250 cc
932-115U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 540 cc
Sientra, Inc.
20942-185U
Not in Commercial Distribution

  • 00812790023080 ()

  • Volume: 540 cc
20942-185U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 435 cc
Sientra, Inc.
20942-180U
Not in Commercial Distribution

  • 00812790023073 ()

  • Volume: 435 cc
20942-180U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 385 cc
Sientra, Inc.
20942-175U
Not in Commercial Distribution

  • 00812790023066 ()

  • Volume: 385 cc
20942-175U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Oval, Single Projection, Textured, 343 cc
Sientra, Inc.
20942-170U
Not in Commercial Distribution

  • 00812790023059 ()

  • Volume: 343 cc
20942-170U

  • Silicone-block tissue reconstructive material
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
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