Address:4900 CHARLEMAR DR.,,CINCINNATI,OH,45227,US
Device Description : Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilaye Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for dermal regeneration. The dermal replacement layer consists of a porous, three-dimensional matrix, comprised of bovine collagen and chondtroitin-6-sulfate (C6S) that is designed with a controlled porosity and defined degradation rate. The temporary epidermal layer is made of a thin polysiloxane (silicone) layer to provide immediate wound coverage and control moisture loss from the wound.
Device Class : 3
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : Omnigraft Kit containing 2.5cm x2.5cm Integra® Omnigraft™ Dermal Regeneration M Omnigraft Kit containing 2.5cm x2.5cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 disposable skin stapler preloaded with 35 staples
Device Class : 3
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design c HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal low pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design c HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design c HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal high pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF fr The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF fr The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainage bag. System components facilitate CSF drainage, CSF sampling and intracranial pressure (ICP) monitoring. Monitoring of intracranial pressure (ICP) is usually performed in selected patients with severe head injury, subarachnoid hemorrhage, Reyes syndrome or similar encephalopathies, hydrocephalus, hydrocephalic shunt infections, intracranial hemorrhage and pre and/or post-operative monitoring.
Device Class : 2
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : creos™ xenotape Absorbable Collagen Wound Dressing for Dental Surgery
Device Class :
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes
Device Description : creos™ xenocote Absorbable Collagen Wound Dressing for Dental Surgery
Device Class :
Duns Number: 083171244
Premarket Exempt : No
Prescription Use : Yes