| Primary Device ID | 16970462546853 |
| NIH Device Record Key | ae95230f-d2a8-4b09-b2e3-4484bbb767c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stone Collector |
| Version Model Number | 180ML-L |
| Company DUNS | 403655303 |
| Company Name | Shenzhen HugeMed Medical Technical Development 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 | 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 | 06970462546856 [Primary] |
| GS1 | 16970462546853 [Package] Contains: 06970462546856 Package: BOX [10 Units] In Commercial Distribution |
| GS1 | 26970462546850 [Package] Contains: 06970462546856 Package: BOX [20 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| 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 |
| 16970462546853 | 180ML-L |
| 06970462546849 | 140mL-S |