| Primary Device ID | D76462017631 |
| NIH Device Record Key | 41bc7560-a9d8-4e61-a616-ca3bb0ef6d93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XIOS+ |
| Version Model Number | 6201763 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, 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 | true |
| 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 | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D76462017631 [Primary] |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-12-09 |
| Device Publish Date | 2016-09-09 |
| D76462243441 | SIRONA XIOS PLUS USB 2 SHIPPING KIT |
| D76462017631 | SIRONA XIOS PLUS SIZE 2 SHIP KIT |
| D76462017551 | SIRONA XIOS PLUS SENSOR SIZE 1 SHIP KIT |