| Primary Device ID | 00840663110575 |
| NIH Device Record Key | 0f69b29f-96ca-4247-aff6-cf44cee5d1c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardioCel Bioscaffold Patch 6 cm X 14 cm |
| Version Model Number | UC0614C |
| Company DUNS | 184805166 |
| Company Name | Lemaitre Vascular, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840663110575 [Primary] |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-18 |
| Device Publish Date | 2024-10-10 |
| 00840663110551 - CardioCel Bioscaffold Patch 4 cm X 4 cm | 2024-10-18 |
| 00840663110568 - CardioCel Bioscaffold Patch 5 cm X 8 cm | 2024-10-18 |
| 00840663110575 - CardioCel Bioscaffold Patch 6 cm X 14 cm | 2024-10-18 |
| 00840663110575 - CardioCel Bioscaffold Patch 6 cm X 14 cm | 2024-10-18 |
| 00840663110605 - CardioCel Neo Bioscaffold Patch 4 cm X 4 cm | 2024-10-18 |
| 00840663110667 - VascuCel Bioscaffold Patch .8 cm X 8 cm | 2024-10-18 |
| 00840663110674 - VascuCel Bioscaffold Patch 1 cm X 14 cm | 2024-10-18 |
| 00840663110773 - CardioCel Neo Bioscaffold Patch 5 cm X 8 cm | 2024-10-18 |
| 00840663110544 - CardioCel Bioscaffold Patch 2 cm X 2 cm | 2024-10-16 |