Device Description : The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospin The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.
Device Class : 2
Duns Number: 078846878
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Galea Elevator is a stainless-steel, reusable, manual surgical instrument de The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when implanting a ventricular shunting system in patients with normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when implanting a ventricular shunting system in patients with normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when implanting a ventricular shunting system in patients with normal skin.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospin The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.
Device Class : 2
Duns Number: 078846878
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between two skin incisions. It is also designed to facilitate the subcutaneous passage of shunt tubing when implanting a ventricular or lumbar cerebrospinal fluid (CSF) shunting system or externalized CSF drain.
Device Class : 1
Duns Number: 078846878
Premarket Exempt : Yes
Prescription Use : Yes