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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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Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 580-690 cc
Sientra, Inc.
AlloX2-16E
In Commercial Distribution

  • 00812790028405 ()

  • Volume: 580-690 cc
AlloX2-16E

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 340-420 cc
Sientra, Inc.
AlloX2-13E
In Commercial Distribution

  • 00812790028375 ()

  • Volume: 340-420 cc
AlloX2-13E

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Ports, Mid Height, 225-280 cc
Sientra, Inc.
AlloX2-12E
In Commercial Distribution

  • 00812790028368 ()

  • Volume: 225-280 cc
AlloX2-12E

  • Skin-port tissue expander
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 650 cc
Sientra, Inc.
20645-650HP
In Commercial Distribution

  • 00812790027873 ()

  • Volume: 650 cc
20645-650HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 625 cc
Sientra, Inc.
20645-625HP
In Commercial Distribution

  • 00812790027866 ()

  • Volume: 625 cc
20645-625HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 335 cc
Sientra, Inc.
20645-335HP
In Commercial Distribution

  • 00812790027804 ()

  • Volume: 335 cc
20645-335HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 270 cc
Sientra, Inc.
20645-270HP
In Commercial Distribution

  • 00812790027798 ()

  • Volume: 270 cc
20645-270HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 210 cc
Sientra, Inc.
20645-210HP
In Commercial Distribution

  • 00812790027781 ()

  • Volume: 210 cc
20645-210HP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Profile, 650 cc
Sientra, Inc.
20645-650LP
In Commercial Distribution

  • 00812790027736 ()

  • Volume: 650 cc
20645-650LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Classic Base, Moderate Profile, 180 cc
Sientra, Inc.
20676-180MP
In Commercial Distribution

  • 00812790027088 ()

  • Volume: 180 cc
20676-180MP

  • Silicone gel-filled breast implant, textured-surface
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