| Primary Device ID | 00813557020243 |
| NIH Device Record Key | 67a50911-6948-49f0-981c-f4ebe5b7cfdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PXL |
| Version Model Number | PXL-1000 |
| Catalog Number | PXL-1000 |
| Company DUNS | 036787190 |
| Company Name | Digital Doc LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813557020243 [Primary] |
| EIA | Unit, Operative Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-29 |
| Device Publish Date | 2025-01-21 |
| 00813557020007 - Iris | 2025-01-29 IRIS USB 2.0 Intraoral Camera |
| 00813557020120 - LuM | 2025-01-29 LUM Sub-Enamel Illumination |
| 00813557020144 - Iris | 2025-01-29 IRIS X80 Intraoral Camera |
| 00813557020151 - LuM | 2025-01-29 LUM X80 & HD Sub Enamel illumination |
| 00813557020205 - Iris | 2025-01-29 IRIS X90 Intraoral Camera |
| 00813557020243 - PXL | 2025-01-29PXL Intraoral Camera |
| 00813557020243 - PXL | 2025-01-29 PXL Intraoral Camera |