| Z-0003-2022 |
Medtronic Perfusion Systems |
2
|
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. |
| Z-0021-2018 |
OriGen Biomedical, Inc. |
2
|
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. |
| Z-0039-2020 |
AZIYO BIOLOGICS |
2
|
BioEnvelope, surgical mesh envelope. Labeled as the following:
1. BioEnvelope (Medium) (single pack);
2. BioEnvelope (Large) (single pack);
3. BioEnvelope (Extra Large) (single pack);
4. BioEnvelope (Extra Extra Large) (single pack);
5. BioEnvelope (Large) (5-pack);
6. BioEnvelope (Medium) (5-pack);
7. BioEnvelope (Extra Extra Large) (5-pack);
8. BioEnvelope (Extra Large) (5-pack)
Product Usage: 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 electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. |
| Z-0040-2020 |
AZIYO BIOLOGICS |
2
|
CanGaroo Envelopes labeled as the following:
1. CanGaroo Envelope (Large) (single pack);
2. CanGaroo Envelope (Medium) (single pack);
3. CanGaroo Envelope (Extra Large) (single pack);
4. CanGaroo Envelope (Extra Extra Large) (single pack);
5. CanGaroo Envelope (Large) (5 pack);
6. CanGaroo Envelope (Medium) (5 pack);
7. CanGaroo Envelope (Extra Large) (5 pack);
8. CanGaroo Envelope (Extra Extra Large) (5 pack)
Product Usage: 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. |
| Z-0041-2024 |
Blue Belt Technologies, Inc |
2
|
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5)
Product Number: ROB10299 |