| Primary Device ID | D76465455401 |
| NIH Device Record Key | d3f1acd6-069e-4b30-892f-c5988924a0d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XIOS XG |
| Version Model Number | 6545540 |
| 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 | false |
| 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 |
|---|---|
| HIBCC | D76465455401 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2016-09-16 |
| D76465455991 | AimRight Aiming Ring, Red 1pc |
| D76465456151 | XIOS XG AimRight Grip Sensor Holder Kit S2 |
| D76465456071 | XIOS XG AimRight Grip Sensor Holder Kit S1 |
| D76465455811 | AimRight Sensor Holder, Ant/Blue S2 2pc |
| D76465455731 | AimRight Sensor Holder, Ant/Blue S1 2pc |
| D76465455651 | AimRight Sensor Holder, BW/Red S2 2pc |
| D76465455571 | AimRight Sensor Holder, BW/Red S1 2pc |
| D76465455401 | AimRight Sensor Holder, PA/Yel. S2 4pc |
| D76465455321 | AimRight Sensor Holder, Posterior/Yellow. S1 4pc |
| D76464112971 | XIOS XG S2 STARTER KIT |
| D76464112891 | XIOS XG S1 STARTER KIT |
| D76461774011 | USB A/B 3M BLACK CABLE REPLACEMENT W/FERRITE |
| D76464099601 | XIOS XG SELECT SIZE 1 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) |
| D76464099521 | XIOS XG SELECT SIZE 2 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) |