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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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CI X - 03662200006281

NOVAE Dual Mobility Acetabular Cup - CI X cross-linked polyethylene liner
SOC ETUDES RECHERCHES FABRICATION
CI 41/22,2 X
In Commercial Distribution

  • 03662200006281 ()


  • Non-constrained polyethylene acetabular liner

OptiCare X - 08592654363188

active integrated anti-decubitus mattresses
L I N E T spol. s r.o.
1VSM000211100
In Commercial Distribution

  • 08592654363188 ()


  • Alternating-pressure bed mattress overlay system

OptiCare X - 08592654271759

active integrated anti-decubitus mattresses
L I N E T spol. s r.o.
1VSK0B0001000
In Commercial Distribution

  • 08592654271759 ()


  • Alternating-pressure bed mattress overlay system

SAPPHIRE X - 00840606163545

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 32MM
SPINAL ELEMENTS, INC.
27002-032
In Commercial Distribution

  • 00840606163545 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163521

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 28MM
SPINAL ELEMENTS, INC.
27002-028
In Commercial Distribution

  • 00840606163521 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163507

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 24MM
SPINAL ELEMENTS, INC.
27002-024
In Commercial Distribution

  • 00840606163507 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163491

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 22MM
SPINAL ELEMENTS, INC.
27002-022
In Commercial Distribution

  • 00840606163491 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163484

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27002-020
In Commercial Distribution

  • 00840606163484 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606162357

SAPPHIRE X® SINGLE LEVEL INSERTER, HANDLE ASSEMBLY
SPINAL ELEMENTS, INC.
27010-000-11
In Commercial Distribution

  • 00840606162357 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606162333

SAPPHIRE X® SINGLE LEVEL INSERTER, INTERNAL SHAFT, SHORT
SPINAL ELEMENTS, INC.
27010-001-02
In Commercial Distribution

  • 00840606162333 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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