| Primary Device ID | 16935835600280 |
| NIH Device Record Key | 4d078496-923f-43cb-b2cb-a098a2945c50 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | HK-Y-0.7 |
| Company DUNS | 410789418 |
| Company Name | Hkable 3D Biologic Printing Technology(Chongqing) 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06935835600283 [Primary] |
| GS1 | 16935835600280 [Package] Contains: 06935835600283 Package: [35 Units] In Commercial Distribution |
| KMY | Positioner, Tooth, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-17 |
| Device Publish Date | 2023-10-09 |
| 16935835600006 - NA | 2023-10-17 |
| 16935835600211 - NA | 2023-10-17 |
| 16935835600228 - NA | 2023-10-17 |
| 16935835600280 - NA | 2023-10-17 |
| 16935835600280 - NA | 2023-10-17 |
| 16935835600303 - NA | 2023-10-17 |
| 16935835600334 - NA | 2023-10-17 |
| 16935835600341 - NA | 2023-10-17 |
| 16935835600358 - NA | 2023-10-17 |