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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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Softspan Tissue Expander - 00812790029112

Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 70-90 cc
Sientra, Inc.
BTE070
In Commercial Distribution

  • 00812790029112 ()

  • Volume: 70-90 cc
BTE070

  • Skin-port tissue expander

SIENTRA Silicone Gel Breast Implant - 00812790020478

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 570 cc
Sientra, Inc.
10521-570HP
In Commercial Distribution

  • 00812790020478 ()

  • Volume: 570 cc
10521-570HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020454

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 520 cc
Sientra, Inc.
10521-520HP
In Commercial Distribution

  • 00812790020454 ()

  • Volume: 520 cc
10521-520HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020430

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 465 cc
Sientra, Inc.
10521-465HP
Not in Commercial Distribution

  • 00812790020430 ()

  • Volume: 465 cc
10521-465HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020416

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 405 cc
Sientra, Inc.
10521-405HP
Not in Commercial Distribution

  • 00812790020416 ()

  • Volume: 405 cc
10521-405HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020393

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 355 cc
Sientra, Inc.
10521-355HP
Not in Commercial Distribution

  • 00812790020393 ()

  • Volume: 355 cc
10521-355HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020355

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 265 cc
Sientra, Inc.
10521-265HP
Not in Commercial Distribution

  • 00812790020355 ()

  • Volume: 265 cc
10521-265HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020331

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 225 cc
Sientra, Inc.
10521-225HP
Not in Commercial Distribution

  • 00812790020331 ()

  • Volume: 225 cc
10521-225HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020317

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 185 cc
Sientra, Inc.
10521-185HP
Not in Commercial Distribution

  • 00812790020317 ()

  • Volume: 185 cc
10521-185HP

  • Silicone gel-filled breast implant, smooth-surface

SIENTRA Silicone Gel Breast Implant - 00812790020294

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 135 cc
Sientra, Inc.
10521-135HP
Not in Commercial Distribution

  • 00812790020294 ()

  • Volume: 135 cc
10521-135HP

  • Silicone gel-filled breast implant, smooth-surface
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