| Primary Device ID | D040600081 |
| NIH Device Record Key | 2ac24d92-25eb-4ba0-9c40-0a7bfede17c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARDENT |
| Version Model Number | 60008 |
| Company DUNS | 006385173 |
| Company Name | WHIP-MIX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D040600081 [Primary] |
| EFH | Paper, Articulation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-06 |
| Device Publish Date | 2023-10-27 |
| D040602061 | Ardent™ Exacta-Film Red/Black |
| D040600130 | Ardent™ Complete Kit- Trial Kit |
| D040600081 | Ardent™ Articulating Paper Quadrant Red Blue Curved .0025 144 Strips 63 microns |