Address:1100 Old Ellis Rd,Roswell,GA,30076,US
Device Description : Tyke is intended for use in neonates and infants for repair of pericardial struc Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
Device Class : 2
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CanGaroo® Envelope is intended to securely hold a cardiac implantable electr The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cordneuromodulators, deep brain stimulators and sacral nerve stimulators.
Device Class : 2
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : VasCure for Vascular Repair is intended for use as a patch material for repair a VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Device Class : 2
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : VasCure for Vascular Repair is intended for use as a patch material for repair a VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Device Class : 2
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BioEnvelope is intended to securely hold a cardiac implantable electronic de The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Device Class :
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BioEnvelope is intended to securely hold a cardiac implantable electronic de The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Device Class :
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BioEnvelope is intended to securely hold a cardiac implantable electronic de The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Device Class :
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BioEnvelope is intended to securely hold a cardiac implantable electronic de The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Device Class :
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BioEnvelope is intended to securely hold a cardiac implantable electronic de The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Device Class : 2
Duns Number: 080251450
Premarket Exempt : No
Prescription Use : Yes