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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 - M543CM6255

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 - 00840606161657

SAPPHIRE X® 1-LEVEL PLATE, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-21
In Commercial Distribution

  • 00840606161657 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161633

SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-19
In Commercial Distribution

  • 00840606161633 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161510

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, BASE
SPINAL ELEMENTS, INC.
27000-000-07
In Commercial Distribution

  • 00840606161510 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606160773

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27001-020
In Commercial Distribution

  • 00840606160773 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606160421

SAPPHIRE X®, AWL-DRILL VARIABLE GUIDE
SPINAL ELEMENTS, INC.
27031-000
In Commercial Distribution

  • 00840606160421 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160353

SAPPHIRE X®, DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27032-018
In Commercial Distribution

  • 00840606160353 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160339

SAPPHIRE X®, DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27032-014
In Commercial Distribution

  • 00840606160339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160315

SAPPHIRE X®, DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27032-010
In Commercial Distribution

  • 00840606160315 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606159982

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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