| Primary Device ID | 60192155302886 |
| NIH Device Record Key | 4a8ab577-159f-4b44-abce-3b22efdd7b59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SINGLE USE SLEEVES - 3D BITE BLOCK |
| Version Model Number | SINGLE USE SLEEVES - 3D BITE BLOCK |
| Catalog Number | 5302880 |
| Company DUNS | 019796106 |
| Company Name | CARESTREAM DENTAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60192155302886 [Primary] |
| KQM | CAMERA, SURGICAL AND ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2018-01-15 |
| 60192155945076 - RIOSensor+ | 2024-01-25 RIOSensor+ Size 1 |
| 60192155945083 - RIOSENSOR+ | 2024-01-25 RIOSENSOR+ SIZE 2 |
| 60192155944864 - CS 8200 3D Access | 2023-12-20 CS 8200 3D ACCESS |
| 60192155944833 - DENTRA III | 2023-06-12 DENTRA III SIZE 1 |
| 60192155944840 - DENTRA III | 2023-06-12 DENTRA III SIZE 2 |
| 60192155944543 - Swissmeda powered by Carestream Dental | 2022-10-31 Swissmeda powered by Carestream Dental |
| 60192155943720 - CS 3800 Wired | 2022-02-21 CS 3800 3D I/O SCANNER WIRED |
| 60192155944482 - CS Model+ | 2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY |