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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 - 00840606162296

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

  • 00840606162296 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606161619

SAPPHIRE X® VARIABLE ANGLE SCREW, CADDY ASSEMBLY
SPINAL ELEMENTS, INC.
27000-000-17
In Commercial Distribution

  • 00840606161619 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161589

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 - 00840606161541

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, CADDY INSERT
SPINAL ELEMENTS, INC.
27000-000-10
In Commercial Distribution

  • 00840606161541 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161527

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, LID
SPINAL ELEMENTS, INC.
27000-000-08
In Commercial Distribution

  • 00840606161527 ()


  • 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 - 00840606161503

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

  • 00840606161503 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606160438

SAPPHIRE X, AWL-DRILL SLEEVE CAP
SPINAL ELEMENTS, INC.
27031-001
Not in Commercial Distribution

  • 00840606160438 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

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 - 00840606160414

SAPPHIRE X®, 10MM AWL
SPINAL ELEMENTS, INC.
27034-000
In Commercial Distribution

  • 00840606160414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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