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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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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
HEPRO.US Syringe 1ml/cc 31 G x 5/16 SINGLE
HEPRO.US INC.
SINGLE - 1ml/cc 31 G x 5/16
In Commercial Distribution

  • 00854427007834 ()


  • Insulin syringe/needle, basic
Disposable Syringe 3ml/cc with 22G x 3/4" Single
HEPRO.US INC.
SINGLE- 3ml/cc 22G x 3/4"
In Commercial Distribution

  • 00854427007704 ()


  • General-purpose syringe, single-use
Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box
Vapocoolshot, Inc
VM01000-00
In Commercial Distribution

  • 00860006961534 ()


  • Biopsy syringe holder, reusable
Dose Drawing Syringe Shield, 10/12 cc, with Replaceable Glass
Mirion Technologies (capintec), Inc.
007-695
In Commercial Distribution

  • 00859942006720 ()
7-695

  • Syringe radiation shield
100 cc Inflation Syringe, single use, non-sterile. Box of 100.
Myriad Medical, LLC
100
In Commercial Distribution

  • 00860005263134 ()
  • 10860005263131 ()
100

  • Catheter/overtube balloon inflator, single-use
LIF, DISTRACTOR, CC OFFSET, 4 x 26 x 60, 0°
ALPHATEC SPINE, INC.
255-12-04266000
In Commercial Distribution

  • 00190376386256 ()

  • Height: 4 Millimeter
  • Depth: 60 Millimeter
  • Width: 26 Millimeter


  • Bone lever/elevator, reusable
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