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-6065T56
In Commercial Distribution

  • 08057432565029 ()


  • 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-6100T55
In Commercial Distribution

  • 08057432565012 ()


  • 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-6095T55
In Commercial Distribution

  • 08057432565005 ()


  • 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-6090T55
In Commercial Distribution

  • 08057432564992 ()


  • 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-6085T55
In Commercial Distribution

  • 08057432564985 ()


  • 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-6080T55
In Commercial Distribution

  • 08057432564978 ()


  • 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-6075T55
In Commercial Distribution

  • 08057432564961 ()


  • 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-6070T55
In Commercial Distribution

  • 08057432564954 ()


  • 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-6065T55
In Commercial Distribution

  • 08057432564947 ()


  • 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-6100T540
In Commercial Distribution

  • 08057432564930 ()


  • 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-6095T540
In Commercial Distribution

  • 08057432564923 ()


  • 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-6090T540
In Commercial Distribution

  • 08057432564916 ()


  • 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-6085T540
In Commercial Distribution

  • 08057432564909 ()


  • 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-6080T540
In Commercial Distribution

  • 08057432564893 ()


  • 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-6075T540
In Commercial Distribution

  • 08057432564886 ()


  • 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-6070T540
In Commercial Distribution

  • 08057432564879 ()


  • 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-6065T540
In Commercial Distribution

  • 08057432564862 ()


  • 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-660T540
In Commercial Distribution

  • 08057432564855 ()


  • 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-655T540
In Commercial Distribution

  • 08057432564848 ()


  • 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-650T540
In Commercial Distribution

  • 08057432564831 ()


  • 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-645T540
In Commercial Distribution

  • 08057432564824 ()


  • 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-640T540
In Commercial Distribution

  • 08057432564817 ()


  • 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-635T540
In Commercial Distribution

  • 08057432564800 ()


  • 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-630T540
In Commercial Distribution

  • 08057432564794 ()


  • 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-620T540
In Commercial Distribution

  • 08057432564770 ()


  • 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-4100T58
In Commercial Distribution

  • 08057432564763 ()


  • 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-4095T58
In Commercial Distribution

  • 08057432564756 ()


  • 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-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
Micro Injection Needle Style II 11ga x 9cm Luer Lockhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Ebner Medical, LLC
AA7771109
In Commercial Distribution

  • 00840217906166 ()

  • Length: 9 Centimeter
  • Outer Diameter: 3.048 Millimeter


  • Surgical/emergency suction cannula, non-illuminating, reusable
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22141
Not in Commercial Distribution

  • 00814356021516 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22140
Not in Commercial Distribution

  • 00814356021509 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22139
Not in Commercial Distribution

  • 00814356021493 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22138
Not in Commercial Distribution

  • 00814356021486 ()


  • Dental appliance fabrication material, ceramic
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