| Primary Device ID | 00872320006464 |
| NIH Device Record Key | 79564cd9-def5-4f98-842d-ce1687f8c754 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acuity Direct X-Ray Photon Detection |
| Version Model Number | 005-00214 |
| Company DUNS | 102422578 |
| Company Name | CAO GROUP, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com | |
| Phone | 866-999-2635 |
| support@amdlasers.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00872320006464 [Primary] |
| MUH | System, X-Ray, Extraoral Source, Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-27 |
| Device Publish Date | 2024-02-19 |
| 00872320006464 | Acuity Direct X-Ray Photon Detection sensor, which converts x-rays directly to a digital image w |
| 00872320006457 | An intraoral x-ray sensor that doesn't require a scintillator, but converts x-ray photons direct |