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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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S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile
Axial Rod Connector, 3.5/6.35. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-0935
Not in Commercial Distribution

  • 10889910059127 ()

  • 3.5/6.35
50-0935

  • Vertebral body prosthesis, non-sterile
Axial Rod Connector, 3.5/3.5. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-0735
Not in Commercial Distribution

  • 10889910059103 ()

  • 3.5/3.5
50-0735

  • Vertebral body prosthesis, non-sterile
An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma.
RANDOX LABORATORIES LIMITED
AL3875
In Commercial Distribution

  • 05055273200225 ()
AL3875

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
The Locking device is an adapter for holding and securing the position of a device with an outside diameter of 2-3 Fr that is inserted through a device with demale luer connector used during interventional of diagnostic procedures.
Promepla
RCG10992ST162
In Commercial Distribution

  • 03700512925514 ()
  • 03700512915515 ()
  • 03700512905516 ()
RCG10992ST162

  • General-purpose catheter connector, sterile
Disposa-Shield® Disposable Barrier For Light Handle (T-Bar). Box of 500
Dentsply Professional
A88008
In Commercial Distribution

  • D003A880082 ()
  • D003A880081 ()
  • D003A880080 ()


  • Cable/lead/sensor/probe cover, non-sterile
physIQ convenience kit including re-supply of biosensors and skin preparation materials.
PHYSIQ, INC
Model H
In Commercial Distribution

  • 00850023120045 ()


  • Electrocardiography telemetric monitoring system
physIQ convenience kit including re-supply of biosensors and skin preparation materials.
PHYSIQ, INC
Model G
In Commercial Distribution

  • 00850023120038 ()


  • Electrocardiography telemetric monitoring system
Com-Fit Plush™ Natural Fit Masks ASTM #3 Box of 40
Sultan Healthcare Inc
20357
In Commercial Distribution

  • D687203572 ()
  • D687203571 ()
  • D687203570 ()


  • Surgical/medical face mask, single-use
Com-Fit Plush™ Natural Fit Masks ASTM #2 Box of 40
Sultan Healthcare Inc
20356
In Commercial Distribution

  • D687203562 ()
  • D687203561 ()
  • D687203560 ()


  • Surgical/medical face mask, single-use
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