| Primary Device ID | 08800017902067 |
| NIH Device Record Key | c02a1885-4a80-4661-8b4c-5b925be57229 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Impression Bite Tray |
| Version Model Number | Sideless |
| Catalog Number | [BT-2000] |
| Company DUNS | 688797315 |
| Company Name | DXM 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800017902067 [Package] Contains: 08800017902074 Package: Box [35 Units] In Commercial Distribution |
| GS1 | 08800017902074 [Primary] |
| EBH | Material, Impression Tray, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-19 |
| Device Publish Date | 2024-06-11 |
| 08800017902098 | Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of |
| 08800017902067 | Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of |
| 08800017902050 | Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of |