aziyo.com
xx.xxCanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large), CanGaroo Enevlope (extra Extra Large) (SubQ)
Aziyo Biologics, Inc.
AZIYO BIOLOGICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005619880 | 3005619880 | AZIYO BIOLOGICS, INC. | 1 | N | 2020-04-25 | 1100 Old Ellis Rd Suite 1200 Roswell GA US 30076 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04035479160647 | Biotronik BioEnvelope - 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. | 470-514-4080 | customerservice@aziyo.com |
| 10859389005017 | ProxiCor for Pericardial Closure - ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery. | 470-514-4080 | xxx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 209175 | 1974842128 | K152127 | CorMatrix Tyke | DXZ | 2016-02-04 |
| 209175 | 1838029059 | K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | DXZ | 2014-07-15 |
| 209175 | 1746234425 | K140306 | CORMATRIX PROTECT ECM ENVELOPE | FTM | 2014-08-15 |
| 209175 | 1897604321 | K111187 | PATCH, PLEDGET AND INTRACARDIAC | DXZ | 2011-07-26 |
| 209175 | 1685799382 | K063349 | CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR | DXZ | 2007-02-16 |
| 209175 | 1975287080 | K051405 | REGENSIS PERICARDIAL PATCH | DXZ | 2005-08-31 |
Product Codes Associated With Registrations#
PMN#
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large), CanGaroo Envelope (extra Extra Large) (SubQ)
Aziyo Biologics, Inc.
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra Large)
Aziyo Biologics, Inc.
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large)
Aziyo Biologics, Inc.
GUDID#
Biotronik BioEnvelope - 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.
2019-08-26
Tyke, Patch, Pledget and Intracardiac - 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.
2019-02-28
CanGaroo Envelope - 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 cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
2019-02-28
CanGaroo Envelope - 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 cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
2015-07-01
CanGaroo Envelope - 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 cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
2015-07-01
CanGaroo Envelope - 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 cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
2015-07-01
CanGaroo Envelope - 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 cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
2015-07-01
ProxiCor for Pericardial Closure - ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery.
2015-06-30
ProxiCor for Cardiac Tissue Repair - ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
2015-06-30
ProxiCor for Cardiac Tissue Repair - ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
2015-07-01
VasCure for Carotid Repair - VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
2015-07-01
VasCure for Carotid Repair - VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
2015-07-01
VasCure for Vascular Repair - 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.
2015-07-01
VasCure for Vascular Repair - 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.
2015-07-01