| Primary Device ID | 06970278690057 |
| NIH Device Record Key | 2a8b708f-106c-4ae2-b656-895b7d5bdb50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | High-speed Turbine Handpieces for Single Use |
| Version Model Number | TBY03-DZJ |
| Company DUNS | 544504276 |
| Company Name | Beijing Dongbo Dental Handpiece Co.,Ltd. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 06970278690057 [Primary] |
| GS1 | 06970278690200 [Package] Package: [10 Units] In Commercial Distribution |
| EFB | Handpiece, Air-Powered, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-11 |
| Device Publish Date | 2018-12-11 |
| 06970278690125 | TBY03-BKJW |
| 06970278690118 | TBY03-BZJW |
| 06970278690101 | TBY03-BZJ |
| 06970278690095 | TBY03-BKJ |
| 06970278690088 | TBY03-BK |
| 06970278690071 | TBY03-DKJW |
| 06970278690064 | TBY03-DZJW |
| 06970278690057 | TBY03-DZJ |
| 06970278690040 | TBY03-DKJ |
| 06970278690033 | TBY03-DK |
| 06970278690026 | TBY04-DZJ |
| 06970278690019 | TBY04-DKJ |
| 06970278690484 | TBY03-XZJ |
| 06970278690477 | TBY03-XKJ |
| 06970278690460 | TBY03-XZJG |
| 06970278690453 | TBY03-BZG |
| 06970278690446 | TBY03-BZ |
| 06970278690439 | TBY03-DKJQ |
| 06970278690422 | TBY03-DZJQ |
| 06970278690293 | TBY03-DKJQW |
| 06970278690408 | TBY03-DZJQW |
| 06970278690392 | TBY03-DZG |
| 06970278690385 | TBY03-DZ |
| 06970278690378 | TBY04-DZJG |