| Primary Device ID | 26970401813913 | 
| NIH Device Record Key | 0caeb448-7ad0-4a87-b138-bd36fa5b81cb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Single Use Guidewire | 
| Version Model Number | MD-S-GW3545 | 
| Company DUNS | 544434963 | 
| Company Name | Zhe Jiang ChuangXiang Medical Technology 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 | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 06970401813490 [Primary] | 
| GS1 | 16970401813909 [Package] Contains: 06970401813490 Package: Box [10 Units] In Commercial Distribution | 
| GS1 | 26970401813913 [Package] Contains: 16970401813909 Package: Case [5 Units] In Commercial Distribution | 
| OCY | Endoscopic Guidewire, 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 | 2019-04-01 | 
| Device Publish Date | 2019-03-23 | 
| 16970401815095 - Disposable Valve Sets | 2020-05-01 | 
| 26970401814286 - Non-Rotatable Snares | 2019-10-31 | 
| 26970401814262 - Non-Rotatable Snares | 2019-10-31 | 
| 26970401814309 - Rotatable Snares | 2019-10-31 | 
| 26970401813739 - Cleaning Brush | 2019-10-07 | 
| 26970401813456 - Cleaning Brush | 2019-10-07 | 
| 26970401813470 - Cleaning Brush | 2019-10-07 | 
| 26970401813647 - Cleaning Brush | 2019-10-07 |