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
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
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