| Primary Device ID | 26970401813845 |
| NIH Device Record Key | 5c74af6a-bec2-488b-aaf0-f37a60502184 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Bite Block |
| Version Model Number | MD-BB-CY-01 |
| Company DUNS | 544434963 |
| Company Name | Zhe Jiang ChuangXiang Medical Technology Co., Ltd. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 06970401812172 [Primary] |
| GS1 | 16970401813831 [Package] Contains: 06970401812172 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 26970401813845 [Package] Contains: 16970401813831 Package: Case [50 Units] In Commercial Distribution |
| MNK | Endoscopic Bite Block |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-26 |
| 26970401813616 | MD-BB-AY-03 |
| 26970401813845 | MD-BB-CY-01 |
| 26970401813586 | MD-BB-AY-01 |