| Primary Device ID | 16936881134231 | 
| NIH Device Record Key | 4e07e129-d2ca-4238-aeac-1f81a21afc90 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ureteral Access Sheath | 
| Version Model Number | U03B011013 | 
| Company DUNS | 544811862 | 
| Company Name | Well Lead Medical 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 06936881134234 [Primary] | 
| GS1 | 16936881134231 [Package] Contains: 06936881134234 Package: Box [5 Units] In Commercial Distribution | 
| GS1 | 26936881134238 [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 | 2024-05-01 | 
| Device Publish Date | 2024-04-23 | 
| 16944932787688 | 12Fr×35cm | 
| 16944932787671 | 10Fr×45cm | 
| 16944932787664 | 14Fr×35cm | 
| 16944932787657 | 10Fr×35cm | 
| 16936881134408 | 14Fr×55cm | 
| 16936881134392 | 14Fr×45cm | 
| 16936881134378 | 14Fr×28cm | 
| 16936881134361 | 14Fr×20cm | 
| 16936881134354 | 14Fr×13cm | 
| 16936881134347 | 12Fr×55cm | 
| 16936881134330 | 12Fr×45cm | 
| 16936881134316 | 12Fr×28cm | 
| 16936881134309 | 12Fr×20cm | 
| 16936881134293 | 12Fr×13cm | 
| 16936881134286 | 10Fr×55cm | 
| 16936881134255 | 10Fr×28cm | 
| 16936881134248 | 10Fr×20cm | 
| 16936881134231 | 10Fr×13cm |