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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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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
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 700 cc
Sientra, Inc.
20645-700MP
Not in Commercial Distribution

  • 00812790021871 ()

  • Volume: 700 cc
20645-700MP

  • 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
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 600 cc
Sientra, Inc.
20645-600MP
Not in Commercial Distribution

  • 00812790021857 ()

  • Volume: 600 cc
20645-600MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 550 cc
Sientra, Inc.
20645-550MP
Not in Commercial Distribution

  • 00812790021840 ()

  • Volume: 550 cc
20645-550MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 500 cc
Sientra, Inc.
20645-500MP
Not in Commercial Distribution

  • 00812790021833 ()

  • Volume: 500 cc
20645-500MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 450 cc
Sientra, Inc.
20645-450MP
Not in Commercial Distribution

  • 00812790021826 ()

  • Volume: 450 cc
20645-450MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 400 cc
Sientra, Inc.
20645-400MP
Not in Commercial Distribution

  • 00812790021819 ()

  • Volume: 400 cc
20645-400MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Profile, 370 cc
Sientra, Inc.
20645-370MP
Not in Commercial Distribution

  • 00812790021802 ()

  • Volume: 370 cc
20645-370MP

  • Silicone gel-filled breast implant, textured-surface
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