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=677511#
SAGEMAX BIOCERAMICS, INC
W-22116
Not in Commercial Distribution

  • 00814356021264 ()


  • Dental appliance fabrication material, ceramic
Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#
UNIFIED SPINE, LLC
502308
In Commercial Distribution

  • M9935023080 ()

  • Height: 8 Millimeter


  • Orthopaedic bone fixation plate spacer
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=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-20
In Commercial Distribution

  • 00841365116841 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-4
In Commercial Distribution

  • 00841365116292 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-15
In Commercial Distribution

  • 00841365114991 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=305583#
BEST MEDICAL INTERNATIONAL, INC.
530-12
In Commercial Distribution

  • 00841365114328 ()


  • General-purpose brachytherapy system applicator, manual
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#
SPES MEDICA SPA
TFDN452501
In Commercial Distribution

  • 18054655015154 ()
  • 08054655015157 ()


  • Electromyographic needle electrode, single-use
UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens
COPAN ITALIA SPA
3C030N.HL
In Commercial Distribution

  • 58053326009117 ()
  • 38053326009113 ()
  • 08053326009112 ()
3C030N.HL

  • General specimen container IVD, additive/medium
UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
COPAN ITALIA SPA
330C.HL
In Commercial Distribution

  • 58053326008974 ()
  • 38053326008970 ()
  • 08053326008979 ()
330C.HL

  • General specimen container IVD, additive/medium
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-760T58
In Commercial Distribution

  • 08057432565388 ()


  • 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-760T57
In Commercial Distribution

  • 08057432565371 ()


  • 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-760T55
In Commercial Distribution

  • 08057432565357 ()


  • 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-760T540
In Commercial Distribution

  • 08057432565340 ()


  • 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-755T540
In Commercial Distribution

  • 08057432565333 ()


  • 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-660T58
In Commercial Distribution

  • 08057432565326 ()


  • 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-655T58
In Commercial Distribution

  • 08057432565319 ()


  • 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-650T58
In Commercial Distribution

  • 08057432565302 ()


  • 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-645T58
In Commercial Distribution

  • 08057432565296 ()


  • 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-640T58
In Commercial Distribution

  • 08057432565289 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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