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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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Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 290 cc
Sientra, Inc.
932-120U
Not in Commercial Distribution

  • 00812790023103 ()

  • Volume: 290 cc
932-120U

  • Silicone-block tissue reconstructive material
Gluteal Implant, Silicone Elastomer, Round, Single Projection, Smooth, 250 cc
Sientra, Inc.
932-115U
Not in Commercial Distribution

  • 00812790023097 ()

  • Volume: 250 cc
932-115U

  • Silicone-block tissue reconstructive material
Silicone Gel Breast Implant, Textured Shaped Round Base, 220 cc
Sientra, Inc.
20646-220RB
Not in Commercial Distribution

  • 00812790021895 ()

  • Volume: 220 cc
20646-220RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Shaped Round Base, 200 cc
Sientra, Inc.
20646-200RB
Not in Commercial Distribution

  • 00812790021888 ()

  • Volume: 200 cc
20646-200RB

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Textured Round, Low Profile, 60 cc
Sientra, Inc.
20610-060LP
Not in Commercial Distribution

  • 00812790021079 ()

  • Volume: 60 cc
20610-060LP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 140 cc
Sientra, Inc.
10610-140LP
Not in Commercial Distribution

  • 00812790020577 ()

  • Volume: 140 cc
10610-140LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 120 cc
Sientra, Inc.
10610-120LP
Not in Commercial Distribution

  • 00812790020560 ()

  • Volume: 120 cc
10610-120LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Low Profile, 60 cc
Sientra, Inc.
10610-060LP
Not in Commercial Distribution

  • 00812790020539 ()

  • Volume: 60 cc
10610-060LP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 425 cc
Sientra, Inc.
10512-425MP
In Commercial Distribution

  • 00812790020195 ()

  • Volume: 425 cc
10512-425MP

  • Silicone gel-filled breast implant, smooth-surface
Silicone Gel Breast Implant, Smooth Round, Moderate Profile, 395 cc
Sientra, Inc.
10512-395MP
In Commercial Distribution

  • 00812790020171 ()

  • Volume: 395 cc
10512-395MP

  • Silicone gel-filled breast implant, smooth-surface
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