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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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The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6X2P2CD
Not in Commercial Distribution

  • M272AU6X2P2CD1 ()
  • 10381780036470 ()

  • 24 platinum contacts


  • Cortical electrode
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4X6P2
Not in Commercial Distribution

  • M272AU4X6P21 ()
  • 10381780036388 ()

  • 24 platinum contacts


  • Cortical electrode
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M85
Not in Commercial Distribution

  • M27240M851 ()
  • 10381780035312 ()

  • 24 platinum contacts


  • Cortical electrode
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M84
Not in Commercial Distribution

  • M27240M841 ()
  • 10381780035305 ()

  • 24 platinum contacts


  • Cortical electrode
No Description
Biomet Orthopedics, LLC
110050024
In Commercial Distribution

  • 00887868571756 ()

  • Size 24 Liner
110050024

  • Acetabular shell
Robinson/Nelaton Catheter
CONVATEC, PURCHASING DEPARTMENT
503429
Not in Commercial Distribution

  • 30768455145929 ()
  • 50768455145923 ()
  • 70768455145927 ()

  • 24 FR 40cm
503429

  • Single-administration urethral drainage catheter
No Description
Dynarex Corporation
36277
In Commercial Distribution

  • 00840117323322 ()
  • 00840117315396 ()
  • 00840117315303 ()


  • Nasopharyngeal airway, single-use
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
REDAX SPA
10526
In Commercial Distribution

  • 18034139296606 ()
  • 08034139296609 ()
10526

  • Closed-wound drain connector
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21824
In Commercial Distribution

  • 18034139293780 ()
  • 08034139293783 ()
21824

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20824
In Commercial Distribution

  • 18034139292844 ()
  • 08034139292847 ()
20824

  • Pleural catheter
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