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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 - 00840606162340

SAPPHIRE X® SINGLE LEVEL INSERTER, INTERNAL SHAFT, LONG
SPINAL ELEMENTS, INC.
27010-003-02
In Commercial Distribution

  • 00840606162340 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606162326

SAPPHIRE X® SINGLE LEVEL INSERTER, EXTERNAL SHAFT, LONG
SPINAL ELEMENTS, INC.
27010-003-01
In Commercial Distribution

  • 00840606162326 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

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 - 00840606161695

SAPPHIRE X® FIXED ANGLE SCREW, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-28
In Commercial Distribution

  • 00840606161695 ()


  • Device sterilization/disinfection container, reusable

SAPPHIRE X - 00840606161664

SAPPHIRE X® 1-LEVEL PLATE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-22
In Commercial Distribution

  • 00840606161664 ()


  • Device sterilization/disinfection container, reusable

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 - 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 - 00840606161602

16MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, LID
SPINAL ELEMENTS, INC.
27000-000-16
In Commercial Distribution

  • 00840606161602 ()


  • 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 - 00840606161565

14MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE
SPINAL ELEMENTS, INC.
27000-000-12
In Commercial Distribution

  • 00840606161565 ()


  • 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 - 00840606161534

SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, INSTRUMENT INSERT
SPINAL ELEMENTS, INC.
27000-000-09
In Commercial Distribution

  • 00840606161534 ()


  • 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 - 00840606160407

SAPPHIRE X®, AWL-DRILL Ø2.0 X 18MM
SPINAL ELEMENTS, INC.
27033-018
In Commercial Distribution

  • 00840606160407 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160384

SAPPHIRE X®, AWL-DRILL Ø2.0 X 14MM
SPINAL ELEMENTS, INC.
27033-014
In Commercial Distribution

  • 00840606160384 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160377

SAPPHIRE X®, AWL-DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27033-012
In Commercial Distribution

  • 00840606160377 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606160360

SAPPHIRE X®, AWL-DRILL Ø2.0 X 10MM
SPINAL ELEMENTS, INC.
27033-010
In Commercial Distribution

  • 00840606160360 ()


  • 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 - 00840606160322

SAPPHIRE X®, DRILL Ø2.0 X 12MM
SPINAL ELEMENTS, INC.
27032-012
In Commercial Distribution

  • 00840606160322 ()


  • 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

SAPPHIRE X - 00840606159968

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 14MM
SPINAL ELEMENTS, INC.
27001-014
In Commercial Distribution

  • 00840606159968 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159937

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 11MM
SPINAL ELEMENTS, INC.
27001-011
In Commercial Distribution

  • 00840606159937 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606159913

1-LEVEL SAPPHIRE X® CERVICAL PLATE, 9MM
SPINAL ELEMENTS, INC.
27001-009
In Commercial Distribution

  • 00840606159913 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606151344

SAPPHIRE X® FIXED DRILL GUIDE 60°
SPINAL ELEMENTS, INC.
27022-060
In Commercial Distribution

  • 00840606151344 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606151337

SAPPHIRE X® FIXED DRILL GUIDE 45°
SPINAL ELEMENTS, INC.
27022-045
In Commercial Distribution

  • 00840606151337 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606151320

SAPPHIRE X® FIXED DRILL GUIDE 30°
SPINAL ELEMENTS, INC.
27022-030
In Commercial Distribution

  • 00840606151320 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606151313

SAPPHIRE X® FIXED DRILL GUIDE 15°
SPINAL ELEMENTS, INC.
27022-015
In Commercial Distribution

  • 00840606151313 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

FlexLab X - 07640172344002

The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.
Inpeco SA
FXX
In Commercial Distribution

  • 07640172344002 ()


  • Specimen processing instrument IVD

CI X - 03662200006403

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 65/28 X
In Commercial Distribution

  • 03662200006403 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006380

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 61/28 X
In Commercial Distribution

  • 03662200006380 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006373

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 59/28 X
In Commercial Distribution

  • 03662200006373 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006366

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 57/28 X
In Commercial Distribution

  • 03662200006366 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006359

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 55/28 X
In Commercial Distribution

  • 03662200006359 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006342

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 53/28 X
In Commercial Distribution

  • 03662200006342 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006335

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 51/28 X
In Commercial Distribution

  • 03662200006335 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006328

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 49/28 X
In Commercial Distribution

  • 03662200006328 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006311

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 47/28 X
In Commercial Distribution

  • 03662200006311 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006298

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 43/22,2 X
In Commercial Distribution

  • 03662200006298 ()


  • Non-constrained polyethylene acetabular liner

CI X - 03662200006397

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 63/28 X
In Commercial Distribution

  • 03662200006397 ()


  • Non-constrained polyethylene acetabular liner
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