| Primary Device ID | 00316837000190 |
| NIH Device Record Key | 56bea7b5-7ce8-46c7-994e-5356feb7ce30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Artegraft Vascular Graft |
| Version Model Number | AG 535 |
| Catalog Number | AG535 |
| Company DUNS | 003683646 |
| Company Name | Artegraft 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 | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 00316837000190 [Primary] |
| LXA | Tissue Graft Of 6mm And Greater |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-08-29 |
| 00316837000350 | 8mm x 30 Cm |
| 00316837000343 | 8mm x 15 cm |
| 00316837000336 | 7mm x 45 cm |
| 00316837000329 | 7mm x 40 cm |
| 00316837000312 | 6mm x 50cm |
| 00316837000305 | 6mm x 45 cm |
| 00316837000299 | 6mm x 40 cm |
| 00316837000282 | 6mm x 35 cm |
| 00316837000275 | 6mm x 30cm |
| 00316837000268 | 6mm x 15 cm |
| 00316837000251 | 5mm x 45 cm |
| 00316837000244 | Artegraft Vascular Graft 5mm x 40 cm |
| 00316837000237 | 5mm x 35cm |
| 00316837000220 | 5mm x 30cm |
| 00316837000213 | 5mm x 16 cm |
| 00316837000206 | 4mm x 40 cm |
| 00316837000190 | 4mm x 35cm |
| 00316837000367 | 7mm x 30cm |