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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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SAPPHIRE X® SINGLE LEVEL INSERTER, SHORT
SPINAL ELEMENTS, INC.
27010-001
In Commercial Distribution

  • 00840606162296 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-17
In Commercial Distribution

  • 00840606161619 ()


  • Device sterilization/disinfection container, reusable
16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-14
In Commercial Distribution

  • 00840606161589 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, CADDY INSERT
SPINAL ELEMENTS, INC.
27000-000-10
In Commercial Distribution

  • 00840606161541 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, LID
SPINAL ELEMENTS, INC.
27000-000-08
In Commercial Distribution

  • 00840606161527 ()


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

  • 00840606161503 ()


  • Device sterilization/disinfection container, reusable
SAPPHIRE X, AWL-DRILL SLEEVE CAP
SPINAL ELEMENTS, INC.
27031-001
Not in Commercial Distribution

  • 00840606160438 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, AWL-DRILL VARIABLE GUIDE
SPINAL ELEMENTS, INC.
27031-000
In Commercial Distribution

  • 00840606160421 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X®, 10MM AWL
SPINAL ELEMENTS, INC.
27034-000
In Commercial Distribution

  • 00840606160414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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