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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, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 75-188 cc
Sientra, Inc.
SRE-FO-075
In Commercial Distribution

  • 00812790029983 ()

  • Volume: 75-188 cc
SRE-FO-075

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Reinforced Base, 60-150 cc
Sientra, Inc.
SRE-FO-060
In Commercial Distribution

  • 00812790029976 ()

  • Volume: 60-150 cc
SRE-FO-060

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Non-reinforced Base, 35-89 cc
Sientra, Inc.
SRE-FO-035
In Commercial Distribution

  • 00812790029969 ()

  • Volume: 35-89 cc
SRE-FO-035

  • Skin-port tissue expander
Tissue Expander, Flat Oval, Textured Surface, Remote Port, Non-reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FO-025
In Commercial Distribution

  • 00812790029952 ()

  • Volume: 25-62 cc
SRE-FO-025

  • Skin-port tissue expander
Tissue Expander, Rectangle, Textured Surface, Remote Port, Reinforced Base, 750-900 cc
Sientra, Inc.
SPR750
In Commercial Distribution

  • 00812790029228 ()

  • Volume: 750-900 cc
SPR750

  • Skin-port tissue expander
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, 600 cc
Sientra, Inc.
20645-600LP
In Commercial Distribution

  • 00812790027729 ()

  • Volume: 600 cc
20645-600LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 695cc
Sientra, Inc.
20721-695MP
In Commercial Distribution

  • 00812790025756 ()

  • Volume: 695 cc
20721-695MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 650cc
Sientra, Inc.
20721-650MP
In Commercial Distribution

  • 00812790025749 ()

  • Volume: 650 cc
20721-650MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 625cc
Sientra, Inc.
20721-625MP
In Commercial Distribution

  • 00812790025732 ()

  • Volume: 625 cc
20721-625MP

  • Silicone gel-filled breast implant
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