Address:105 and 109 MORGAN LANE,PLAINSBORO,NJ,08536,US
Device Description : Integra™ Ventricular Drainage System provides a sterile path for the drainage of Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal fluid (CSF) from an intraventricular catheter to a collection bag. The system can be used for external drainage, and the management of hydrocephalic shunt infections, or treatment of other cerebral conditions such as pre-operative or post-operative pressure monitoring of CSF to control increased intracranial pressure.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within t Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within t Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within t Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within t Sundt™ Internal Carotid Endarterectomy Shunt is designed for placement within the artery and used to provide temporary carotid bypass for cerebral circulation during carotid endartectomy procedures.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Silicone Coated Brain Retractors are fabricated with polyester reinforced sil Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Device Class : 1
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Silicone Coated Brain Retractors are fabricated with polyester reinforced sil Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Device Class : 1
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Silicone Coated Brain Retractors are fabricated with polyester reinforced sil Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Device Class : 1
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Silicone Coated Brain Retractors are fabricated with polyester reinforced sil Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Device Class : 1
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Silicone Coated Brain Retractors are fabricated with polyester reinforced sil Silicone Coated Brain Retractors are fabricated with polyester reinforced silicone elastomer, covering a malleable stainless steel core, used for tissue retraction in neurosurgical procedures.
Device Class : 1
Duns Number: 083171244
Premarket Exempt : Yes
Prescription Use : Yes