Address:1655 Roberts Blvd NW,Kennesaw,GA,30144,US
Device Description : The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution fo The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.HeRO Graft consists of two primary components:• A proprietary Venous Outflow Component• A proprietary Arterial Graft ComponentThe HeRO Graft Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip.
Device Class : 2
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution fo The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.HeRO Graft consists of two primary components:• A proprietary Venous Outflow Component• A proprietary Arterial Graft ComponentThe HeRO Graft Arterial Graft Component has a 6mm ID, 7.4mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.
Device Class : 2
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution fo The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.HeRO Graft consists of two primary components:• A proprietary Venous Outflow Component• A proprietary Arterial Graft ComponentThe HeRO Graft Accessory Components provides instruments and accessories (such as, peel away sheaths and dilators, stylet, disposable clamp, hemostasis plug and hemostatic Y-valve with stopcock) that may aid in the placement of the HeRO Graft.
Device Class : 2
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : SolarGen 2100s Holmium:YAG Laser Console
Device Class : 3
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : SoloGrip III Handpiece Delivery System
Device Class : 3
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : Pearl 5.0 Handpiece Delivery System
Device Class : 3
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : BioGlue Surgical Adhesive Applicator Tips
Device Class : 3
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : BioGlue Surgical Adhesive Syringe Extender Tips
Device Class :
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : BioGlue Surgical Adhesive Syringe Extender Tips
Device Class : 3
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes
Device Description : BioGlue Surgical Adhesive Syringe Spreader Tips
Device Class :
Duns Number: 119253177
Premarket Exempt : No
Prescription Use : Yes