Address:2905 ROUTE DES DOLINES,Sophia Antipolis CEDEX Alpes-Maritimes,FR
Device Description : The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in the bullet-shaped tip and a stainless steel handle. The introducer is designed to be used with a sheath (inner diameter: 4 mm) to make a subcutaneous tunnel between two incisions for the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. When ordering additional sheaths, specify Catalog No. 901118 (46 cm).
Device Class : 1
Duns Number: 531408342
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Integra 61 cm Peritoneal Introducer is a reusable, stainless steel obturator The Integra 61 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in the bullet-shaped tip and a stainless steel handle. The introducer is designed to be used with a sheath (inner diameter: 4 mm) to make a subcutaneous tunnel between two incisions for the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. When ordering additional sheaths, specify Catalog No. 901124 (61 cm).
Device Class : 1
Duns Number: 531408342
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite bas 20 cm Radiopaque Straight Ventricular Catheter with large holes and graphite based length marks at 5, 10, 15 cm from the tip.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Connectors are implantable accessories intended to be used with Integra Hydrocep Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Connectors are implantable accessories intended to be used with Integra Hydrocep Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Connectors are implantable accessories intended to be used with Integra Hydrocep Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Connectors are implantable accessories intended to be used with Integra Hydrocep Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Connectors are implantable accessories intended to be used with Integra Hydrocep Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Integra DP Valve System is an implantable device which serves as a parallel flow Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes
Device Description : Integra DP Valve System is an implantable device which serves as a parallel flow Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired.
Device Class :
Duns Number: 531408342
Premarket Exempt : No
Prescription Use : Yes