| Primary Device ID | 09348992000549 |
| NIH Device Record Key | 50e9ad89-b498-4858-baa0-21165f339122 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardioCel 3D |
| Version Model Number | UC0406A |
| Catalog Number | C0406A |
| Company DUNS | 741172167 |
| Company Name | ADMEDUS REGEN PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com | |
| Phone | +61892660100 |
| info@admedus.com |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Angle | 60 degree |
| Length | 6 Centimeter |
| Width | 4 Centimeter |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348992000549 [Primary] |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2019-03-21 |
| 09348992000549 | CardioCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. T |
| 09348992000358 | CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog |
| 09348992000334 | CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog |
| 09348992000327 | CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog |
| 09348992000280 | UC0406A |