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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https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4090T58
In Commercial Distribution

  • 08057432564749 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-4085T58
In Commercial Distribution

  • 08057432564732 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-430T58
In Commercial Distribution

  • 08057432564725 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T56
In Commercial Distribution

  • 08057432564718 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-460T55
In Commercial Distribution

  • 08057432564701 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-455T55
In Commercial Distribution

  • 08057432564695 ()


  • Trans-facet-screw internal spinal fixation system, sterile
Silicone Gel Breast Implant, Smooth Round, High Profile, 700 cc
Sientra, Inc.
10721-700HP
In Commercial Distribution

  • 00812790025855 ()

  • Volume: 700 cc
10721-700HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 650 cc
Sientra, Inc.
10721-650HP
In Commercial Distribution

  • 00812790025848 ()

  • Volume: 650 cc
10721-650HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 620 cc
Sientra, Inc.
10721-620HP
In Commercial Distribution

  • 00812790025831 ()

  • Volume: 620 cc
10721-620HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 590 cc
Sientra, Inc.
10721-590HP
In Commercial Distribution

  • 00812790025824 ()

  • Volume: 590 cc
10721-590HP

  • Silicone gel-filled breast implant
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