| Primary Device ID | E27659326032 |
| NIH Device Record Key | 55b678ce-7ed8-40e3-9dc7-d4344db87da9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sleeve for extraoral X-Ray devices |
| Version Model Number | 5932603 |
| Company DUNS | 340306351 |
| Company Name | SIRONA Dental Systems GmbH |
| Device Count | 100 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com | |
| Phone | +4962511670 |
| contact@sirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27659326032 [Primary] |
| HIBCC | E276593260320 [Unit of Use] |
| OAS | X-Ray, Tomography, Computed, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-30 |
| Device Publish Date | 2016-09-10 |
| E27661849022 | Hygienic protective for handle |
| E27661848942 | Hygienic protective for forehead |
| E27661277452 | Hygienic protective sleeve for 3 D-bite |
| E27662344002 | Hygienic protective head holder GALILEOS |
| E27662343922 | Hygienic protective forehead GALILEOS |
| E27659682632 | Hygienic protective for forehead |
| E27659682552 | Hygienic protective for handle |
| E27659326032 | Hygienic protective for chin rest a. bar |
| E27633141062 | Covers for brow bar, 100 pcs. |
| E27633140802 | Hygienic protective sleeve f. bite block |
| E27633140722 | Hygienic protective sleeve f. bite block |