| Primary Device ID | 16959664910747 |
| NIH Device Record Key | 122f67ad-ee94-4d57-a89b-d163a3d8afca |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | AG-5453-10-12-15 |
| Company DUNS | 542984702 |
| Company Name | Hangzhou AGS MedTech 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06959664910740 [Primary] |
| GS1 | 16959664910747 [Package] Contains: 06959664910740 Package: box [5 Units] In Commercial Distribution |
| GS1 | 26959664910744 [Package] Package: carton [50 Units] In Commercial Distribution |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-17 |
| Device Publish Date | 2022-10-09 |
| 16959664911959 - NA | 2023-04-10 |
| 16959664911966 - NA | 2023-04-10 |
| 16959664913496 - NA | 2023-04-10 |
| 16959664934279 - NA | 2023-04-10 |
| 16959664934316 - NA | 2023-04-10 |
| 16959664902087 - NA | 2022-10-20 |
| 16959664902100 - NA | 2022-10-20 |
| 16959664902162 - NA | 2022-10-20 |