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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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SIENTRA Silicone Gel Breast Implant - 00812790020324

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

SIENTRA Silicone Gel Breast Implant - 00812790020300

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

SIENTRA Silicone Gel Breast Implant - 00812790020287

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

Softspan Tissue Expander - 00812790029990

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

Softspan Tissue Expander - 00812790029983

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

Softspan Tissue Expander - 00812790029884

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

Softspan Tissue Expander - 00812790029877

Tissue Expander, Low Rectangle, Textured Surface, Remote Port, Reinforced Base, 160-320 cc
Sientra, Inc.
SRE-LR-160
In Commercial Distribution

  • 00812790029877 ()

  • Volume: 160-320 cc
SRE-LR-160

  • Skin-port tissue expander

Softspan Tissue Expander - 00812790029839

Tissue Expander, Crescent, Smooth Surface, Remote Port, Reinforced Base, 45-90 cc
Sientra, Inc.
SRE-CR-045S
In Commercial Distribution

  • 00812790029839 ()

  • Volume: 45-90 cc
SRE-CR-045S

  • Skin-port tissue expander

Softspan Tissue Expander - 00812790029822

Tissue Expander, Crescent, Textured Surface, Remote Port, Reinforced Base, 350-700 cc
Sientra, Inc.
SRE-CR-350
In Commercial Distribution

  • 00812790029822 ()

  • Volume: 350-700 cc
SRE-CR-350

  • Skin-port tissue expander

Softspan Tissue Expander - 00812790029815

Tissue Expander, Crescent, Textured Surface, Remote Port, Reinforced Base, 200-400 cc
Sientra, Inc.
SRE-CR-200
In Commercial Distribution

  • 00812790029815 ()

  • Volume: 200-400 cc
SRE-CR-200

  • Skin-port tissue expander
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