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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 - 00812790020270

Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 95 cc
Sientra, Inc.
10521-095HP
Not in Commercial Distribution

  • 00812790020270 ()

  • Volume: 95 cc
10521-095HP

  • 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 - 00812790029976

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

Softspan Tissue Expander - 00812790029969

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

Softspan Tissue Expander - 00812790029952

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

Softspan Tissue Expander - 00812790029228

Tissue Expander, Rectangle, Textured Surface, Remote Port, Reinforced Base, 750-900 cc
Sientra, Inc.
SPR750
In Commercial Distribution

  • 00812790029228 ()

  • Volume: 750-900 cc
SPR750

  • Skin-port tissue expander

SIENTRA Silicone Gel Breast Implant - 00812790027781

Silicone Gel Breast Implant, Textured Shaped Oval Base, High Profile, 210 cc
Sientra, Inc.
20645-210HP
In Commercial Distribution

  • 00812790027781 ()

  • Volume: 210 cc
20645-210HP

  • Silicone gel-filled breast implant, textured-surface

SIENTRA Silicone Gel Breast Implant - 00812790027729

Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Profile, 600 cc
Sientra, Inc.
20645-600LP
In Commercial Distribution

  • 00812790027729 ()

  • Volume: 600 cc
20645-600LP

  • Silicone gel-filled breast implant, textured-surface

SIENTRA Silicone Gel Breast Implant - 00812790025756

Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 695cc
Sientra, Inc.
20721-695MP
In Commercial Distribution

  • 00812790025756 ()

  • Volume: 695 cc
20721-695MP

  • Silicone gel-filled breast implant
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