| Primary Device ID | 16970462547591 |
| NIH Device Record Key | 978d3c3d-9516-479d-87b9-a973b12d4f82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single-use Ureteral Access Sheath |
| Version Model Number | Y-12-36 |
| Company DUNS | 403655303 |
| Company Name | Shenzhen HugeMed Medical Technical Development 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970462547594 [Primary] |
| GS1 | 16970462547591 [Package] Contains: 06970462547594 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 26970462547598 [Package] Package: Carton [10 Units] In Commercial Distribution |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-18 |
| Device Publish Date | 2026-02-10 |
| 16970462546815 | Y-12-50 |
| 16970462546808 | Y-12-40 |
| 16970462546792 | Y-11-50 |
| 16970462546778 | Y-10-50 |
| 06970462546764 | Y-10-40 |
| 06970462546757 | Y-09-50 |
| 06970462546740 | Y-09-40 |
| 16970462547614 | Y-12-55 |
| 16970462547607 | Y-12-45 |
| 16970462547591 | Y-12-36 |
| 16970462547584 | Y-11-55 |
| 16970462547577 | Y-11-45 |
| 16970462547560 | Y-11-36 |
| 16970462547553 | Y-10-55 |
| 16970462547546 | Y-10-45 |
| 16970462547539 | Y-10-36 |
| 16970462547522 | Y-09-55 |
| 16970462547515 | Y-09-45 |
| 16970462547508 | Y-09-36 |
| 16970462547492 | Y-08-55 |
| 16970462547485 | Y-08-50 |
| 16970462547478 | Y-08-45 |
| 16970462547461 | Y-08-40 |
| 16970462547454 | Y-08-36 |