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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, Smooth Round, Moderate High Profile, 335 cc
Sientra, Inc.
10521-335HP
Not in Commercial Distribution

  • 00812790020386 ()

  • Volume: 335 cc
10521-335HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 315 cc
Sientra, Inc.
10521-315HP
Not in Commercial Distribution

  • 00812790020379 ()

  • Volume: 315 cc
10521-315HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 285 cc
Sientra, Inc.
10521-285HP
Not in Commercial Distribution

  • 00812790020362 ()

  • Volume: 285 cc
10521-285HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 245 cc
Sientra, Inc.
10521-245HP
Not in Commercial Distribution

  • 00812790020348 ()

  • Volume: 245 cc
10521-245HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 205 cc
Sientra, Inc.
10521-205HP
Not in Commercial Distribution

  • 00812790020324 ()

  • Volume: 205 cc
10521-205HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 165 cc
Sientra, Inc.
10521-165HP
Not in Commercial Distribution

  • 00812790020300 ()

  • Volume: 165 cc
10521-165HP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 115 cc
Sientra, Inc.
10521-115HP
Not in Commercial Distribution

  • 00812790020287 ()

  • Volume: 115 cc
10521-115HP

  • Silicone gel-filled breast implant, smooth-surface
Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Non-reinforced Base, 25-62 cc
Sientra, Inc.
SRE-FO-025S
In Commercial Distribution

  • 00812790029990 ()

  • Volume: 25-62 cc
SRE-FO-025S

  • Skin-port tissue expander
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, Low Rectangle, Textured Surface, Remote Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SRE-LR-200
In Commercial Distribution

  • 00812790029884 ()

  • Volume: 200-400 cc
SRE-LR-200

  • Skin-port tissue expander
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