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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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PENCAN® - 04046964180842

Pencan® 24 Ga. x 4 in. (100 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) - Includes DuraPrep®
B. BRAUN MEDICAL INC.
333867
In Commercial Distribution

  • 04046964180842 ()
  • 04046964180835 ()

  • Gauge (cannula) : 24
333867

  • Intrathecal anaesthesia set, non-medicated

Perifix® - 04046964179983

24 Ga. x 28 in. Polyamide/Polyurethane PERIFIX® ONE Pediatric Catheter - closed tip with catheter connector and threading assist guide
B. BRAUN MEDICAL INC.
333538
In Commercial Distribution

  • 04046964179983 ()
  • 04046964179976 ()

  • Gauge (Catheter) : 24
333538

  • Epidural anaesthesia set, non-medicated

PENCAN® - 04046964181047

Pencan® 24 Ga. x 4 in (100 mm) Spinal Needle with 20 Ga. Introducer
B. BRAUN MEDICAL INC.
333884
In Commercial Distribution

  • 04046964181047 ()
  • 04046964181030 ()

  • Gauge (cannula) : 24
333884

  • Spinal needle, single-use

PENCAN® - 04046964180866

Pencan® 24 Ga. x 4 in. (100 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit)
B. BRAUN MEDICAL INC.
333868
In Commercial Distribution

  • 04046964180866 ()
  • 04046964180859 ()

  • Gauge (cannula) : 24
333868

  • Intrathecal anaesthesia set, non-medicated

Pencan® - 04046964941290

P24BKN 24G PENCAN TRAY W/BUP & DEX NRFIT
B. BRAUN MEDICAL INC.
339181
In Commercial Distribution

  • 04046964941290 ()
  • 04046964941283 ()

  • Gauge (cannula) : 24
339181

  • Intrathecal anaesthesia set, non-medicated

Design Options® - 04046955672011

SSK ADVENTHEALTH ORLANDO
B. BRAUN MEDICAL INC.
560675
In Commercial Distribution

  • 04046955672004 ()
  • 04046955672011 ()

  • Gauge (cannula) : 24
560675

  • Intrathecal anaesthesia set, medicated

Auragen™ - 10381780036470

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

Auragen™ - 10381780036388

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

Auragen™ - 10381780035312

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

Auragen™ - 10381780035305

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
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