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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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BioWick X 5.5mm Pre-Loaded Implant
CAYENNE MEDICAL, INC.
CM-6255
In Commercial Distribution

  • M543CM6255 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
SAPPHIRE X® 1-LEVEL PLATE, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-21
In Commercial Distribution

  • 00840606161657 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-19
In Commercial Distribution

  • 00840606161633 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, BASE
SPINAL ELEMENTS, INC.
27000-000-07
In Commercial Distribution

  • 00840606161510 ()


  • Device sterilization/disinfection container, reusable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27001-020
In Commercial Distribution

  • 00840606160773 ()


  • Spinal fixation plate, non-bioabsorbable
SAPPHIRE X®, AWL-DRILL VARIABLE GUIDE
SPINAL ELEMENTS, INC.
27031-000
In Commercial Distribution

  • 00840606160421 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27032-018
In Commercial Distribution

  • 00840606160353 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27032-014
In Commercial Distribution

  • 00840606160339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27032-010
In Commercial Distribution

  • 00840606160315 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
1-LEVEL SAPPHIRE X® CERVICAL PLATE, 18MM
SPINAL ELEMENTS, INC.
27001-018
In Commercial Distribution

  • 00840606159982 ()


  • Spinal fixation plate, non-bioabsorbable
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