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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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PaediGAV® - 04041906131333

PAEDIGAV WITH PRECHAMBER 9/24
Christoph Miethke GmbH & Co. KG
MIETHKE-40640924
In Commercial Distribution

  • 04041906131333 ()

  • Pressure rating vert. (cmH2O) : 24.000 CWS
  • Pressure rating horiz. (cmH2O) : 9.000 CWS
MIETHKE-40640924

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906131319

PAEDIGAV WITH PRECHAMBER 4/24
Christoph Miethke GmbH & Co. KG
MIETHKE-40640424
In Commercial Distribution

  • 04041906131319 ()

  • Pressure rating vert. (cmH2O) : 24.000 CWS
  • Pressure rating horiz. (cmH2O) : 4.000 CWS
MIETHKE-40640424

  • Cerebrospinal fluid shunt valve

PaediGAV® - 04041906131302

PAEDIGAV WITH PRECHAMBER 4/19
Christoph Miethke GmbH & Co. KG
MIETHKE-40640419
Not in Commercial Distribution

  • 04041906131302 ()

  • Pressure rating horiz. (cmH2O) : 4.000 CWS
  • Pressure rating vert. (cmH2O) : 19.000 CWS
MIETHKE-40640419

  • Cerebrospinal fluid shunt valve

OPTRELL - 10846835023022

Mapping Catheter with TRUEref Technology
Biosense Webster Inc
D140902
In Commercial Distribution

  • 10846835023022 ()
D140902

  • Cardiac mapping catheter, percutaneous, single-use

OPTRELL - 10846835023015

Mapping Catheter with TRUEref Technology
Biosense Webster Inc
D140901
In Commercial Distribution

  • 10846835023015 ()
D140901

  • Cardiac mapping catheter, percutaneous, single-use

PROSA - 04041906142742

PROSA SYS WITH PED.CONTROL RESERVOIR
Aesculap AG
FV821T
In Commercial Distribution

  • 04041906142742 ()
FV821T

  • Ventriculo-peritoneal/atrial shunt

PROSA - 04041906142230

PROSA SYS WITH PED.SPRUNG RESERVOIR
Aesculap AG
FV811T
Not in Commercial Distribution

  • 04041906142230 ()
FV811T

  • Ventriculo-peritoneal/atrial shunt

proGAV 2.0® - 04041906140885

PROGAV 2.0 SYSTEM WITH PRECHAMBER
Christoph Miethke GmbH & Co. KG
FX536T
Not in Commercial Distribution

  • 04041906140885 ()
FX536T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906140823

PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR
Christoph Miethke GmbH & Co. KG
FX307T
Not in Commercial Distribution

  • 04041906140823 ()
FX307T

  • Cerebrospinal fluid shunt valve

proGAV 2.0® - 04041906140816

PROGAV 2.0 WITH CONTROL RESERVOIR
Christoph Miethke GmbH & Co. KG
FX300T
Not in Commercial Distribution

  • 04041906140816 ()
FX300T

  • Cerebrospinal fluid shunt valve
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