| Primary Device ID | 00860007727900 |
| NIH Device Record Key | fcb2912b-bd39-4073-b012-6a0723a62b1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CrossFAST(TM) |
| Version Model Number | CFM55 |
| Company DUNS | 117103735 |
| Company Name | Vantis 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 | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00860007727900 [Primary] |
| GS1 | 10860007727907 [Package] Package: Carton [1 Units] In Commercial Distribution |
| GS1 | 20860007727904 [Package] Contains: 10860007727907 Package: Shipper [5 Units] In Commercial Distribution |
| GS1 | 30860007727901 [Package] Contains: 10860007727907 Package: Shipper [1 Units] In Commercial Distribution |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-14 |