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 Type Device Class Implantable

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Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 205 cc
Sientra, Inc.
GS10621-205HP
In Commercial Distribution

  • 00819409023554 ()

  • Volume: 205 cc
GS10621-205HP

  • Invasive breast implant sizer, fixed, single-use
Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 190 cc
Sientra, Inc.
GS10621-190HP
In Commercial Distribution

  • 00819409023547 ()

  • Volume: 190 cc
GS10621-190HP

  • Invasive breast implant sizer, fixed, single-use
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, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 340-680 cc
Sientra, Inc.
SRE-LR-340S
In Commercial Distribution

  • 00812790029945 ()

  • Volume: 340-680 cc
SRE-LR-340S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 250-500 cc
Sientra, Inc.
SRE-LR-250S
In Commercial Distribution

  • 00812790029938 ()

  • Volume: 250-500 cc
SRE-LR-250S

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

  • 00812790029921 ()

  • Volume: 200-400 cc
SRE-LR-200S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Smooth Surface, Remote Port, Reinforced Base, 160-320 cc
Sientra, Inc.
SRE-LR-160S
In Commercial Distribution

  • 00812790029914 ()

  • Volume: 160-320 cc
SRE-LR-160S

  • Skin-port tissue expander
Tissue Expander, Low Rectangle, Textured Surface, Remote Port, Reinforced Base, 340-680 cc
Sientra, Inc.
SRE-LR-340
In Commercial Distribution

  • 00812790029907 ()

  • Volume: 340-680 cc
SRE-LR-340

  • Skin-port tissue expander
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