| Primary Device ID | 08052870660718 |
| NIH Device Record Key | 664e3b4f-f591-463d-a77c-d9fb6089a34e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Owandy Radiology |
| Version Model Number | Elios |
| Company DUNS | 439922846 |
| Company Name | DENTAL XRAY COMPANY SRL |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08052870660718 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2019-07-01 |
| 08052870660015 - Acteon | 2019-07-09 |
| 08052870660022 - Acteon | 2019-07-09 |
| 08052870660213 - Dental X-Ray Company | 2019-07-09 |
| 08052870660312 - Dental X-Ray Company | 2019-07-09 |
| 08052870660411 - Dental X-Ray Company | 2019-07-09 |
| 08052870660510 - Dental X-Ray Company | 2019-07-09 |
| 08052870660619 - Dental X-Ray Company | 2019-07-09 |
| 08052870660718 - Owandy Radiology | 2019-07-09 |
| 08052870660718 - Owandy Radiology | 2019-07-09 |