No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00859389005102 | CMCV-098-204 | 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. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | Tyke, Patch, Pledget and Intracardiac | |
2 | 00859389005010 | CMCV-060-402 | ProxiCor for Pericardial Closure is a decellularized natural scaffold for repair ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | ProxiCor for Pericardial Closure | |
3 | 00859389005003 | CMCV-059-401 | ProxiCor for Pericardial Closure is a decellularized natural scaffold for repair ProxiCor for Pericardial Closure is a decellularized natural scaffold for repairing the pericardium following cardiac surgery. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | ProxiCor for Pericardial Closure | ||
4 | 00859389005140 | CMCV-013-609 | 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. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | VasCure for Vascular Repair | |
5 | 00859389005126 | CMCV-011-606 | 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. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | VasCure for Vascular Repair | |
6 | 00859389005096 | CMCV-073-609 | VasCure for Carotid Repair is indicated for use as a patch material for vascular 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. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | VasCure for Carotid Repair | |
7 | 00859389005089 | CMCV-072-606 | VasCure for Carotid Repair is indicated for use as a patch material for vascular 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. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | VasCure for Carotid Repair | |
8 | 00859389005058 | CMCV-067-404 | ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | ProxiCor for Cardiac Tissue Repair | |
9 | 00859389005041 | CMCV-064-401 | ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing. | DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | ProxiCor for Cardiac Tissue Repair | |
10 | 04035479160548 | 440578 | 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. | FTM | Mesh, Surgical | Biotronik BioEnvelope | ||
11 | 04035479160531 | 440577 | 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. | FTM | Mesh, Surgical | Biotronik BioEnvelope | ||
12 | 04035479160524 | 440576 | 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. | FTM | Mesh, Surgical | Biotronik BioEnvelope | ||
13 | 04035479160517 | 440575 | 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. | FTM | Mesh, Surgical | Biotronik BioEnvelope | ||
14 | 00859389005119 | CMCV-009-XXL | 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. | FTM | Mesh, Surgical | 2 | CanGaroo Envelope | |
15 | 00859389005072 | CMCV-009-XLG | 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. | FTM | Mesh, Surgical | 2 | CanGaroo Envelope | |
16 | 00859389005065 | CMCV-009-LRG | 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. | FTM | Mesh, Surgical | 2 | CanGaroo Envelope | |
17 | 00859389005034 | CMCV-009-MED | 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. | FTM | Mesh, Surgical | 2 | CanGaroo Envelope | |
18 | 00859389005027 | CMCV-009-SML | 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. | FTM | Mesh, Surgical | 2 | CanGaroo Envelope |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00889024458963 | 32-5014-56 | 32-5014-056-00 | NA | ZIMMER, INC. | |
2 | 00889024458956 | 32-5014-53 | 32-5014-053-00 | NA | ZIMMER, INC. | |
3 | 00868623000360 | XI-S+ | XI0404-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
4 | 00868623000353 | XI-S+ | XI0203-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
5 | 00868623000346 | XI-S+ | XI0710-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
6 | 00868623000339 | XI-S+ | XI0808-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
7 | 00868623000322 | XI-S+ | XI0508-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
8 | 00868623000315 | XI-S+ | XI0615-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
9 | 00868623000308 | XI-S+ | XI0606-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
10 | 00860002305141 | XI-S+ | XI0909C-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
11 | 00860002305134 | XI-S+ | XI1014B-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
12 | 00860002305127 | XI-S+ | XI1014A-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
13 | 00860002305110 | XI-S+ | XI1116B-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
14 | 00860002305103 | XI-S+ | XI1116A-S+ | Colorado Therapeutics Xenograft Implant | COLORADO THERAPEUTICS LLC | |
15 | 00859389005119 | CMCV-009-XXL | 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. | CanGaroo Envelope | AZIYO BIOLOGICS, INC. | |
16 | 00859389005072 | CMCV-009-XLG | 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. | CanGaroo Envelope | AZIYO BIOLOGICS, INC. | |
17 | 00859389005065 | CMCV-009-LRG | 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. | CanGaroo Envelope | AZIYO BIOLOGICS, INC. | |
18 | 00859389005034 | CMCV-009-MED | 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. | CanGaroo Envelope | AZIYO BIOLOGICS, INC. | |
19 | 00859389005027 | CMCV-009-SML | 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. | CanGaroo Envelope | AZIYO BIOLOGICS, INC. | |
20 | 00856072005142 | R20243-1122P | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
21 | 00857072005057 | BLM-100-01-1020 | Biologic Matrix | MIROMESH® | REPRISE BIOMEDICAL, INC. | |
22 | 00857072005040 | BLM-100-01-1016 | Biologic Matrix | MIROMESH® | REPRISE BIOMEDICAL, INC. | |
23 | 00857072005033 | BLM-100-01-0816 | Biologic Matrix | MIROMESH® | REPRISE BIOMEDICAL, INC. | |
24 | 00857072005026 | BLM-100-01-1010 | Biologic Matrix | MiroFlex® | REPRISE BIOMEDICAL, INC. | |
25 | 00857072005019 | BLM-100-01-0808 | Biologic Matrix | MiroFlex® | REPRISE BIOMEDICAL, INC. | |
26 | 00857072005002 | BLM-100-01-0608 | Biologic Matrix | MiroFlex® | REPRISE BIOMEDICAL, INC. | |
27 | 00856072005289 | R20252-1020G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
28 | 00856072005197 | R20253-1122G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
29 | 00856072005135 | R20243-1018P | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
30 | 00856072005111 | R20153-2020G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
31 | 00856072005104 | R20153-1620G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
32 | 00856072005074 | R20143-2020P | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
33 | 00856072005043 | R20143-0416P | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
34 | 00856072005036 | R20252-1122G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
35 | 00856072005029 | R20252-0815G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
36 | 00856072005012 | R20152-2020G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
37 | 00856072005005 | R20152-1620G | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | OviTex® PRS | TELA BIO, INC. | |
38 | 00855638007033 | 3102-2152 | Acellular dermal matrix | ProLayer Xenograft | STELLEN MEDICAL, LLC | |
39 | 00855638007026 | 3102-2147 | Acellular Dermal Matrix | ProLayer Xenograft | STELLEN MEDICAL, LLC | |
40 | 00855638007019 | 3102-2144 | Acellular Dermal Matrix | ProLayer Xenograft | STELLEN MEDICAL, LLC | |
41 | 00855638007002 | 3102-2125 | Acellular Dermal Matrix | ProLayer Xenograft | STELLEN MEDICAL, LLC | |
42 | 00854501006036 | 2999-3 | Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Large | SMITH & NEPHEW, INC. | ||
43 | 00854501006029 | 2999-2 | Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Medium | SMITH & NEPHEW, INC. | ||
44 | 00840663106349 | e10P16 | e10P16 | XenoSure Biologic Patch, 10cm x 16cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
45 | 00840663106332 | e8P14 | e8P14 | XenoSure Biologic Patch, 8cm x 14cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
46 | 00840663106325 | e4P6 | e4P6 | XenoSure Biologic Patch, 4cm x 6cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
47 | 00840663106318 | e4P4 | e4P4 | XenoSure Biologic Patch, 4cm x 4cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
48 | 00840663106301 | e2P9 | e2P9 | XenoSure Biologic Patch, 2cm x 9cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
49 | 00840663106295 | e0.8P8 | e0.8P8 | XenoSure Biologic Patch, 0.8cm x 8cm, eIFU | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |
50 | 00840663106288 | e1P6 | e1P6 | XenoSure Biologic Patch, 1cm x 6cm | XenoSure Biologic Patch | LEMAITRE VASCULAR, INC. |