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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 Profile, 100 cc
Sientra, Inc.
10512-100MP
Not in Commercial Distribution

  • 00812790020010 ()

  • Volume: 100 cc
10512-100MP

  • Silicone gel-filled breast implant, smooth-surface
Tissue Expander, Smooth Surface, Remote Port, Mid Height, 460-550 cc
Sientra, Inc.
LPP14-RS
In Commercial Distribution

  • 00812790028962 ()

  • Volume: 460-550 cc
LPP14-RS

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Remote Port, Mid Height, 310-370 cc
Sientra, Inc.
LPP12-RS
In Commercial Distribution

  • 00812790028948 ()

  • Volume: 310-370 cc
LPP12-RS

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Remote Port, Mid Height, 580-690 cc
Sientra, Inc.
LPP16-R
In Commercial Distribution

  • 00812790028924 ()

  • Volume: 580-690 cc
LPP16-R

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Remote Port, Mid Height, 460-550 cc
Sientra, Inc.
LPP14-R
In Commercial Distribution

  • 00812790028900 ()

  • Volume: 460-550 cc
LPP14-R

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Remote Port, Mid Height, 310-370 cc
Sientra, Inc.
LPP12-R
In Commercial Distribution

  • 00812790028887 ()

  • Volume: 310-370 cc
LPP12-R

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Integrated Port, Full Height, 600-720 cc
Sientra, Inc.
LPP-FH15S
In Commercial Distribution

  • 00812790028856 ()

  • Volume: 600-720 cc
LPP-FH15S

  • Skin-port tissue expander
Tissue Expander, Smooth Surface, Integrated Port, Full Height, 360-430 cc
Sientra, Inc.
LPP-FH13S
In Commercial Distribution

  • 00812790028832 ()

  • Volume: 360-430 cc
LPP-FH13S

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Port, Full Height, 360-430 cc
Sientra, Inc.
LPP-FH13
In Commercial Distribution

  • 00812790028719 ()

  • Volume: 360-430 cc
LPP-FH13

  • Skin-port tissue expander
Tissue Expander, Textured Surface, Integrated Port, Full Height, 250-300 cc
Sientra, Inc.
LPP-FH11
In Commercial Distribution

  • 00812790028696 ()

  • Volume: 250-300 cc
LPP-FH11

  • Skin-port tissue expander
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